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	09/11/2017
Type of Reportable Event	Malfunction
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.Product image review: submitted image appears to display implant fracture around the screw boss flange.
Event or Problem Description
It was reported that during a spinal surgery, the product broke.No fragments of the product remained inside the patient's body.No patient complications were reported as a result of this event.

• 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: 6950681
• Report Number: 1030489-2017-02192
• Device Sequence Number: 1011139
• Product Code: ODP
• UDI-Device Identifier: 00613994502087
• UDI-Public: 00613994502087
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

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: 12/07/2024
• Device Catalogue Number: 4210564
• Device Lot Number: 44DF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR