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

Catalog Number 3992209

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that the patient underwent posterior lumbar fusion surgery at l4/5 and transforaminal lumbar interbody fusion surgery at l5/s using cage.Reportedly, post-op, the cage backed out.Hence, revision surgery was performed in which the cage at l5/s was removed and then iliac bone was transplanted.

• 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: 7040797
• MDR Text Key: 92314471
• Report Number: 1030489-2017-02354
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169187542
• UDI-Public: 00643169187542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172199
• 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
• Report Date: 11/17/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 3992209
• Device Lot Number: H5311090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2016
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 102