MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL SPINAL SYSTEM

Catalog Number	4011227
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
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
It was reported that the patient underwent a surgery due to non-union.Intra-op, the implant broke on insertion at l2-l3.The broken implanted was completely explanted; and was replaced with a new one.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the threads on the backside of the spacer are stripped.There is some damage to the threaded hole on the outside where the inserter attaches to the implant.The implant appears to be deformed and slightly twisted.This is consistent with overload from a bending/twisting motion with the inserter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9539420
• Report Number: 1030489-2020-00007
• Device Sequence Number: 2641793
• Product Code: MAX
• UDI-Device Identifier: 00643169108844
• UDI-Public: 00643169108844
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120368
• 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
• Report Date (Section B): 03/30/2020

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: 4011227
• Device Lot Number: H5550350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR