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

Catalog Number	4011222
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• MDR Report Key: 7042446
• Report Number: 1030489-2017-02361
• Device Sequence Number: 1916006
• Product Code: MAX
• UDI-Device Identifier: 00643169109070
• UDI-Public: 00643169109070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2025
• Device Catalogue Number: 4011222
• Device Lot Number: H5356140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR