MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC THREADED INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2980001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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
Pre-op medical history: posterior lumbar decompression and fixation.It was reported that during surgery, part of the cage holder shaft was broken during insertion and allocation of the cage during interbody fusion.The device came in contact with the patient.The procedure was completed with another set of cage holder.No patient complications occurred due to this event.
Additional Manufacturer Narrative
Product analysis: visual examination confirms the top tang is broken; the broken piece is missing and not returned for analysis.Fracture initiation appears to be located at the base of the tang, consistent with bend stress overload.Microscopic examination of the fracture surface reveals a fairly quasi-brittle fracture, with no indication of fatigue.Conclusion: the above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: THREADED INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7380613
• Report Number: 1030489-2018-00476
• Device Sequence Number: 1392908
• Product Code: MAX
• UDI-Device Identifier: 00721902996689
• UDI-Public: 00721902996689
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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 Catalogue Number: 2980001
• Device Lot Number: MA05D089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 84