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

Catalog Number	G6626746
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code (ove): 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.
Event or Problem Description
It was reported that intra-op, the lateral edges of the implant broke when the implants were tamped for insertion.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Additional information: product analysis: the implant was returned with a crack running 180 degrees around the smaller cross-sectional material at the screw hole.Per the event description, the implant was fracture when the awl with into the screw hole.This is consistent with the lack of witness marks on the top of the implant or around the inserter location holes.If the awl placed pressure on the on it i.D.Of the hole the outward pressure could cause the implant to fracture.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: 6867807
• Report Number: 1030489-2017-02051
• Device Sequence Number: 13675663
• Product Code: OVE
• UDI-Device Identifier: 00643169337473
• UDI-Public: 00643169337473
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 07/06/2025
• Device Catalogue Number: G6626746
• Device Lot Number: H5370411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR