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

Catalog Number	2990822
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other: pain, pseudarthrosis.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Radiographic image review result: post-op x-ray for l2-3, l4-5, l3-4 fusion shown.There appear to be two separate areas of posterior instrumentation at l2-3 and l4-5 but maybe the rod had spurred all of the levels and fractured.An interbody shaft is present at l2-3.A shaft present at l3-4 but the rod doesn't spur this segment.At l4-5 the interbody shaft appear to be positioned posteriorly.I am unfamiliar with the indications for this type of construct.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent tlif (transforaminal lumbar interbody fusion) at l4/5 and fixation was performed at l3/4/5/s2ai with screws due to cage backed out and dysraphism occurred.Post-op, cage backed out because bone fusion was not achieved in the initial surgery.Bone fusion was not achieved because the cage had just been reinserted and bone graft had just been performed in the intervertebral space again.Hence on (b)(6) 2020, a revision surgery (it was a re-operation for the operation of the fourth time) was performed in which the cage was removed, and the screws at l2, l4 and l5 were removed.This was the fifth time for mob cases.The patient felt pain in lower extremity.

• Brand Name: CAPSTONE 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: 10211084
• Report Number: 1030489-2020-00752
• Device Sequence Number: 11330946
• Product Code: MAX
• UDI-Device Identifier: 00613994291042
• UDI-Public: 00613994291042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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 Catalogue Number: 2990822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: Other; Required Intervention
• Patient Age: 63 YR