MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM

Catalog Number	G6626745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: intervertebral fusion device with integrated fixation, cervical.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
Pre-op diagnosis: c6/7 myelopath procedure: c6/7 anterior cervical discectomy and fusion(acdf) it was reported that during surgery, the implant split when the surgeon impacted the inserter to push the implant into place.No fragments were remained in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: the locking mechanism on the top of the implant has broken off.The angle of the break is consistent with pressure being placed downward on one side to the lock.This is consistent with to locking mechanism being struck during implantation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7037869
• Report Number: 1030489-2017-02348
• Device Sequence Number: 16430253
• Product Code: OVE
• UDI-Device Identifier: 00643169337534
• UDI-Public: 00643169337534
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 02/14/2025
• Device Catalogue Number: G6626745
• Device Lot Number: H5326360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1