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

Catalog Number	3992210
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Disability (2371); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two lots of the suspect device was identified, however it is unknown which one is the complaint product.The lots that were used lot h5294239, lot no.H5301699.(b)(4).Device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the re ported event.Product image review: review of submitted images did not identify significant material deformation, crack or fracture.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) at l4-5.In the surgery 2 cages were implanted.The rear part of one of the cages was placed at the same position as the posterior wall at l5.The surgery was performed without problem.However, postoperatively, the cage placed at the same position with posterior wall at l5 was found to be backed-out excessively.Cauda equine was pressured by the backed-out cage which caused pain.The patient suffered disability due to this event.Only one cage was backed out but it is unknown which one backed out.
Additional Manufacturer Narrative
Additional information: x rays image review: l4-5 plif performed by placing two cages from same side.10x22 mm interbody grafts were placed.Post op xrays show these to be placed very laterally and one of the cage is backed out.Suspect the lateral interbody space cannot accommodate these size grafts.
Additional Manufacturer Narrative
Product analysis: visual and optical examination did not identify crack, fracture, or significant deformation.Dimensional examination of the overall length, width, and height found the implant conforms to print specifications.Visual comparison of the complaint returned implant form with sample comparison part did not identify material deviation from design form.Unable to determine root cause of the implant migration from the available information.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: 6700102
• Report Number: 1030489-2017-01729
• Device Sequence Number: 854693
• Product Code: MAX
• UDI-Device Identifier: 00643169187535
• UDI-Public: 00643169187535
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2017

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: 10/03/2024
• Device Catalogue Number: 3992210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 07/11/2017; 09/15/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/07/2017; 10/11/2017
• 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: 33 YR