MAUDE Adverse Event Report: MSD DEGGENDORF MFG PEEK PREVAIL CERVICAL INTERBODY DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	4210564
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure or technique used: anterior cervical discectomy pre-operative diagnosis: cervical spine instability it was reported that intra-op, implant broke during the implantation.The product came in contact with the patient.No patient symptoms or complications were reported in this event.
Additional Manufacturer Narrative
Product analysis: visual review confirmed the implant is broken at the base of the vertebral spacer portion of the implant, with asymmetrical deformation at the top and bottom of the face of the implant, consistent with significant impaction forces during attempted implantation.Microscopic examination of the fracture identified a fairly brittle fracture surface, with rays emanating from the origin of crack propagation.The above observations are consistent with overload during attempted insertion of the implant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEEK PREVAIL CERVICAL INTERBODY DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 7865839
• Report Number: 1030489-2018-01243
• Device Sequence Number: 1703446
• Product Code: ODP
• UDI-Device Identifier: 00613994502087
• UDI-Public: 00613994502087
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2025
• Device Catalogue Number: 4210564
• Device Lot Number: 84EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1