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

Catalog Number	G6626747
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with cervical myelopathy and underwent anterior cervical disectomy and fusion at c3-c4.During the surgery, the implant broke upon insertion.There is no fragment of the implant remaining in the patient.There were no patient symptoms or complications as a result of this event.No treatment or additional surgery was performed as a result of this event.
Additional Manufacturer Narrative
Product analysis result: visual optical visual and optical inspection confirmed 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 fractured upon insertion.This is consistent with the lack of witness marks on the top of the implant or around the inserter location holes.If an instrument placed pressure on the inside diameter 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: 8233833
• Report Number: 1030489-2019-00036
• Device Sequence Number: 216697
• Product Code: OVE
• UDI-Device Identifier: 00643169337411
• UDI-Public: 00643169337411
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 04/09/2023
• Device Catalogue Number: G6626747
• Device Lot Number: H5168413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR