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

Catalog Number X0912057

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2018

Event Type  Injury  

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 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.

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.

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
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7777075
• MDR Text Key: 116903942
• Report Number: 1030489-2018-01128
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00643169306370
• UDI-Public: 00643169306370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 10/30/2018
• Supplement Dates FDA Received: 09/10/2018; 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR