MAUDE Adverse Event Report: MSD DEGGENDORF MFG ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	5030841
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
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: post-op x-ray and delayed post-op x-rays provided for c5-6 acdf (anterior cervical discectomy and fusion) showed subsidence of the graft at the specimen level.This was a peek interbody graft, size unknown.Initial hardware placement appeared appropriate, contributing factors might include removal of the bony cortical endplate during disc space preparation.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 decompression and fusion at c5/6 due to cervical disc herniation.Post -op, the patient suffered with pain in the left shoulder blades.Loss of lordosis, cage sinking, and displacement of plates were observed about 2 weeks after the operation.The event also caused change in the alignment which led to scapular bone pain.

• Brand Name: ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 7034254
• Report Number: 1030489-2017-02340
• Device Sequence Number: 126804
• Product Code: ODP
• UDI-Device Identifier: 00643169357495
• UDI-Public: 00643169357495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 03/18/2024
• Device Catalogue Number: 5030841
• Device Lot Number: 60BK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS
• Outcome Attributed to Adverse Event: Other