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

Catalog Number	3992208
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	11/01/2018
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
Pre-operative diagnosis: spondylolisthesis procedure: posterior lumbar interbody fusion level implanted: l4/5 it was reported that the patient underwent procedure where in two screws were inserted at l4 and two screws were inserted at l5 through plif procedure.Post-op, cage backed out.Revision surgery was performed and cage was removed and decompression was performed.No fragment remains in the patient.Due to cage backing out the cage compressed the nerve and neurological symptoms was reported as result of this event.

• 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: 8102555
• Report Number: 1030489-2018-01549
• Device Sequence Number: 1734458
• Product Code: MAX
• UDI-Device Identifier: 00643169187559
• UDI-Public: 00643169187559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 05/23/2025
• Device Catalogue Number: 3992208
• Device Lot Number: H5352493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/26/2018
• 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: Other; Required Intervention