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

Catalog Number	4210664
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2016
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2016, intra-op, product breakage was found and surgeon had to replace product with a new one to complete the surgery successfully.The patient got interbody fusion due to cervical disc herniation.No patient complications were reported.
Additional Manufacturer Narrative
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: 6116048
• Report Number: 1030489-2016-03194
• Device Sequence Number: 18854345
• Product Code: ODP
• UDI-Device Identifier: 00613994502094
• UDI-Public: 00613994502094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2016

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: 06/07/2024
• Device Catalogue Number: 4210664
• Device Lot Number: 71CE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR