Failure to report a design change and to conduct proper design validation for its porcine xenograft particulate in syringe landed Collagen Matrix an FDA warning letter.
The Oakland, N.J.-based company manufactures collagen-based finished devices for use in oral/maxillofacial, neurosurgery and orthopedic-spine surgery.
The Sept. 30 warning letter said the instructions for use for the Zcore porcine xenograft syringe indicate that the porcine material in the syringe is hydrated with osseous coagulum, patient blood or sterile saline by pulling and pushing the syringe stoppers.
The firm conducted a functional assessment study, but no design validation study was conducted to ensure that the product conformed to defined user needs, the letter said.
Complaints indicated that the porcine material in the syringe was difficult to eject, and the firm later removed the product from distribution.
The agency said the product was adulterated because the company didn’t have an approved premarket application or an investigational device exemption. The FDA also said the product was misbranded because the firm failed to notify the agency of modifications before marketing.
Specifically, the firm made significant design changes to the MatrixOss Granules (Zcore porcine xenograft particulate) since its initial 510(k) clearance in July 2014, and “such changes could significantly affect the safety and effectiveness of the device,” the letter said.
The FDA explained that when the agency cleared the product, it was in a plastic jar surrounded by an outer blister package. But packaging the Zcore product in a syringe presents “biocompatibility and sterilization validation concerns,” the FDA said, noting that another 510(k) is required to demonstrate that the polymers used in the syringe applicator don’t give off leachables or extractables that could contaminate the biocompatibility of the materials.
In addition, sterilization validation via a 510(k) is required to demonstrate acceptable sterility assurance for the syringe in new packaging.
Read the warning letter here: www.fdanews.com/10-06-16-Collagenwarning.pdf. — Tamra Sami