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 Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that the patient underwent anterior cervical discectomy and fusion at levels c3-c4 and c4-c5.On (b)(6) 2017, one month after the surgery, x-rays revealed that the nitinol wire in the device which works as a locking mechanism in restricting screw pull out, was found to be broken from one end.No patient complications were reported.
Additional Manufacturer Narrative
Additional information: x-ray image review.X-ray review: "post op x-rays from c3-4,c4-5 anterior cervical discectomy and fusion performed with 2 interbody devices show screw back out and wire fracture in the inferior screw at c3-4.This device is indicated for single level use.This construct falls outside of the ifu." 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: 6685555
• Report Number: 1030489-2017-01670
• Device Sequence Number: 13487136
• Product Code: ODP
• UDI-Device Identifier: 00613994502087
• UDI-Public: 00613994502087
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073285
• 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,Followup
• Report Date (Section B): 07/11/2017

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: 05/11/2024
• Device Catalogue Number: 4210564
• Device Lot Number: 94CB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1