MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	9193007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Procedure: discectomy levels treated: l2-l5 it was reported that during surgery, the tail of implant broke.The surgeon inserted the previous two levels l4-l5 <(>&<)> l3-l4 well.The last cage l2-l3 was implanted into distracted vertebral body but when the surgeon did the last impact, the tail of the implant broke.The surgeon removed the debris of the cage from the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual review confirms only two small pieces of the implant are returned for analysis.After completed analysis, no evidence was found that would suggest a defect in design or manufacturing of the implant.Microscopic examination of the returned fragments identified the inserter interface portion of the implant, with a fairly flat fracture and rays emanating away from the area of crack initiation, consistent with significant impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 6299488
• Report Number: 1030489-2017-00234
• Device Sequence Number: 19223371
• Product Code: MQP
• UDI-Device Identifier: 00885074520667
• UDI-Public: 00885074520667
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K052261
• 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,Followup
• Report Date (Section B): 04/26/2017

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: 12/08/2019
• Device Catalogue Number: 9193007
• Device Lot Number: H11L2765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided; 04/26/2017
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 05/10/2017; 09/28/2017
• 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