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

Catalog Number	3992209
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
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
Initial surgery procedure: fixation was performed at t10-s1 it was reported that on an unknown date, post-op, the cage at the right side of l5/s backed out.Re-operation was performed for decompression and fusion for extending.During re-operation, s1 screw was removed, s2ai screw was installed and decompression was performed.The backed out cage did not move and fixation was performed again at t10-s2a.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE PTC 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: 7724526
• Report Number: 1030489-2018-01058
• Device Sequence Number: 1329800
• Product Code: MAX
• UDI-Device Identifier: 00643169187542
• UDI-Public: 00643169187542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2024
• Device Catalogue Number: 3992209
• Device Lot Number: H5307398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR