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 Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Perforation of Esophagus (2399)
Type of Reportable Event	Serious Injury
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
It was reported that the patient underwent anterior cervical discectomy and fusion due to myelopathy.On an unknown date, post-op, the screw of the reported product backed-out from the construct.The backed-out screw perforated the esophagus and caused pain to the patient.The string that holds in the screw was also broken.Hence, a revision surgery was performed on (b)(6) 2019, wherein the implant was removed and was replaced by with plates.Patient was reported to be suffering with injury even after the revision surgery.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination identified deformation around both bone screw flange hole diameters, and deformation at the posterior wall of both of the holes and both wires have been broken.This is 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: 9086266
• Report Number: 1030489-2019-01039
• Device Sequence Number: 2298015
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2026
• Device Catalogue Number: 4210564
• Device Lot Number: 96GE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR