MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2982001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent direct lateral interbody fusion at l4-l5 due to stenosis and spondylolisthesis.Intra-op, the instrument broke.The product came in contact with the patient.No fragment of the broken product remained inside the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual examination confirmed the upper and lower tang/prong of the threaded inserter have broken off; the broken pieces are missing and not returned for analysis.Fracture initiation appears to be located at the base of the tang, consistent with bend stress overload.Optical examination of the fracture surface reveals a fracture, with no indication of fatigue, and a sheer lip which suggests the direction of fracture.The above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8324796
• Report Number: 1030489-2019-00128
• Device Sequence Number: 13941680
• Product Code: MQP
• UDI-Device Identifier: 00885074549736
• UDI-Public: 00885074549736
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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 Catalogue Number: 2982001
• Device Lot Number: PR11L012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR