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

Catalog Number	5030541
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Stenosis (2263)
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 on patient was pre-operatively diagnosed with cervical spondylotic myelopathy and underwent anterior cervical decompression and fusion.Post-op, the cage moved forward after the operation.The intervertebral disc height maintained in the operation decreased, the foraminal stenosis, intervertebral foramen joint worked and neurological symptom were reported as the result of the event.

• 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: 8097248
• Report Number: 1030489-2018-01519
• Device Sequence Number: 13915963
• Product Code: ODP
• UDI-Device Identifier: 00643169357587
• UDI-Public: 00643169357587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 5030541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/21/2018
• 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