MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	G6626745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: model# g6626745, lot# h5199027.Visual examination of the returned implant confirmed that the top center portion of the implant around the locking cap is fractured in multiple locations.Microscopic examination of the fractures appears to emanate from the locking cap, with witness marks on the top face of the locking tab is noted, consistent with impact during attempted implantation.The above observations are consistent with significant impaction force on the implant locking cap during the attempted insertion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider via a manufacturer representative regarding a patient with cervical foraminal stenosis for spinal therapy.It was reported that intra-operatively, product was tamped into final position with a bone punch and the implant fractured.There were no patient symptoms or complications associated with this event.

• Brand Name: DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 11620485
• Report Number: 1030489-2021-00455
• Device Sequence Number: 17118055
• Product Code: OVE
• UDI-Device Identifier: 00643169337534
• UDI-Public: 00643169337534
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 07/20/2023
• Device Model Number: G6626745
• Device Catalogue Number: G6626745
• Device Lot Number: H5199027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/06/2021
• 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