MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTE-STAC SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	6287641
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Product image review: submitted image appears to display implant broken into multiple pieces.
Event or Problem Description
It was reported that the patient underwent anterior cervical discectomy and fusion on c4-5 due to cervical disc protrusion.Intra-op, during insertion of the implant in the patient's body when surgeon was taping the implant with mallet, the implant broke.The implant was explanted on the procedure date itself.No fragments of the implant are remained in the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis result: visual microscopic from the microscopic examination of the fracture face, it appears that the fracture was the result of an impact overload.Compression led to a bending moment and failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTE-STAC SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6816023
• Report Number: 1030489-2017-01954
• Device Sequence Number: 132247
• Product Code: MQP
• UDI-Device Identifier: 00885074347639
• UDI-Public: 00885074347639
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K052931
• 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): 01/25/2018

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: 03/08/2025
• Device Catalogue Number: 6287641
• Device Lot Number: H5344800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1