MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 4011222

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Pre-operative diagnosis for this procedure: lumbar canal stenosis type of procedure used: transforaminal lumbar interbody fusion levels implanted: l5-s1 it was reported that during surgery, inserter came off from a cage during rotation.When the cage was pulled out to confirm, it was found to be slightly deformed and the threads were broken.The cage was changed to one size smaller cage, and it was placed without problem.The product came in contact with the patient.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product analysis:the spacer was returned deformed from what appears to be a twisting motion.There is damaged noted at some points that interface with the inserter and the center section has collapsed from the twisting motion.This damage appears to be the result of torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7042446
• MDR Text Key: 93055091
• Report Number: 1030489-2017-02361
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169109070
• UDI-Public: 00643169109070
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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: 4011222
• Device Lot Number: H5356140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR