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

Catalog Number 3992210

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Disability (2371); No Code Available (3191)

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6700102
• MDR Text Key: 79573236
• Report Number: 1030489-2017-01729
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169187535
• UDI-Public: 00643169187535
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3992210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR