MAUDE Adverse Event Report: MSD DEGGENDORF MFG PEEK PREVAIL CERVICAL INTERBODY DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Lot Number	47CG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2016, patient presented with pre-operative diagnosis: degenerative disk disease of cervical spine.Patient had both pain <(>&<)> symptoms of neurological deficit.For which patient underwent anterior cervical diskectomy and fusion (acdf).Intra-op, while implanting, the implant was impacted as per steps of surgical technique for a snug fit.Surgeon was not happy with the positioning of the implant.Implant was slightly retracted back <(>&<)> again impacted on.During this procedure the posterior half of the implant broke.More than half of the 'i' of 'i-beam' designed implant got separated from the anterior elements of the implant.The product came in contact with the patient.No fragment of the implant remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirmed the implant is broken at the base of the vertebral spacer portion of the implant, with asymmetrical deformation at the top and bottom of the face of the implant, consistent with significant impaction forces during attempted implantation.Microscopic examination of the fracture identified a fairly brittle fracture surface, with rays emanating from the origin of crack propagation, and the inserter threaded hole stripped to the depth of the fracture surface.The above observations are consistent with overload during attempted insertion of the implant.
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: 6140447
• Report Number: 1030489-2016-03324
• Device Sequence Number: 212060
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2017

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: 06/29/2024
• Device Lot Number: 47CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided; 02/06/2017
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 03/03/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR