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

Catalog Number	3992608
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported 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 transforaminal lumbar interbody fusion at l4-l5.Around two months post-op, when the patient underwent x-ray examination, it was found that the cage had backed-out from its position.The patient also complained of lower extremity pain.Hence, on (b)(6) 2019, the patient underwent a revision surgery, in which the backed-out cage was removed and was replaced with a cage of different size.Patient's condition was reported to have improved now.
Additional Manufacturer Narrative
Radiological image review results: post-op ct image of l4-l5 psf shows back out of the interbody graft.Initial implant date was (b)(6) 2018.Fusion is not expected to have occurred.Cage is 40-50% out of interbody space.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: 8568356
• Report Number: 1030489-2019-00504
• Device Sequence Number: 11221607
• Product Code: MAX
• UDI-Device Identifier: 00643169187443
• UDI-Public: 00643169187443
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 3992608
• Device Lot Number: H5454381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: 74 YR
• Patient Weight: 50