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	Dysphagia/ Odynophagia (1815); Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: post-op x-rays for c3-c4 anterior cervical discectomy and fusion shows progressive back-out of the interior screw at different time intervals.The patient has multiple (3+) levels fused below the construct and the fusion appears complete.Initial placement appears satisfactory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent fusion and fixation at c3-c4 due to degeneration and myelopathy.The alleged device was implanted during this surgery.On an unknown date, post-op, the screw slipped out of the implant after breaking the locking wire and got stuck in the esophagus.Allegedly, this led to pain and swallowing issues.Hence, on (b)(6) 2019, the patient underwent a revision surgery.The broken wire was recovered but the screw could not be recovered.It was found that the screw was hidden inside the esophagus and opening the esophagus was more risky.The screw can still be seen on x-ray.Patient is recovering with the screw in his throat with continued problems but minimal pain.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: 9438507
• Report Number: 1030489-2019-01402
• Device Sequence Number: 17194040
• Product Code: ODP
• UDI-Device Identifier: 00613994502087
• UDI-Public: 00613994502087
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K073285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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 Catalogue Number: 4210564
• Device Lot Number: 66HJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 03/18/2020; 03/08/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/28/2020; 04/02/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 80