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

Catalog Number	X0912057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) surgery at l4-s1 levels.During surgery, the tip of inserter was broken.The broken tip of the inserter remained in the patient.The product came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
Additional information: x-ray review: intraoperative imaging for l4-s1 tlif provided.Pedicle screws are present bilaterally in each of the operative levels.By report, a portion of one of the inserter tools for the interbody graft fractured and remained in the patient.It is not clear to me on this image where that occured.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Visual and microscopic examination identified that part of the tip of the inserter is sheared off and missing.This damage is consistent with overload through non-parallel pressure put on the handle.There are witness marks noted on the back side of the inserter that are consistent with impaction.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT¿ SPINAL SYSTEM
• 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: 7777075
• Report Number: 1030489-2018-01128
• Device Sequence Number: 1757828
• Product Code: MQP
• UDI-Device Identifier: 00643169306370
• UDI-Public: 00643169306370
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110543
• 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,Followup
• Report Date (Section B): 11/26/2018

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: X0912057
• Device Lot Number: TI18A006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 10/30/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/10/2018; 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR