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

Catalog Number	5001022
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
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 reported event.H10: x-ray review: post-op x-ray s for l2- l5 plif received.There is a posterior migration of the cage at l4-l5.It is difficult to tell which side this occurred on.The implant date is (b)(6) 2018, so fusion should not have occurred.It would be useful to see intra-op imaging to tell where the cage was placed initially.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: lcs (lumbar canal stenosis) procedure: plif(posterior lumbar interbody fusion) levels implanted: l3-l5 it was reported that post-op, cage backed out.Explant was planned.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis result: visual dimensional microscopic there does not appear to be an issue with the spacer.The size of the spacer was checked and meets print spec.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL 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: 8173009
• Report Number: 1030489-2018-01663
• Device Sequence Number: 16581370
• Product Code: MAX
• UDI-Device Identifier: 00643169679740
• UDI-Public: 00643169679740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2019

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 Expiration Date: 03/13/2026
• Device Catalogue Number: 5001022
• Device Lot Number: H5405670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 04/26/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/28/2019; 04/30/2019
• 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