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

Catalog Number 5021322

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-op diagnosis: thoracolumbar vertebra kyphoscoliosis procedure used: t9-s2ai plif (posterior lumbar interbody fusion) it was reported that intra-op, spacers were used at l5/s but were not able to rotate properly and hence were removed by position adjustment.The threaded part of spacers broke during pulling.No fragments remained in the patient.No patient complications occurred as a result of the event.

Manufacturer Narrative

Product analysis: visual and optical inspection confirmed the threads of the spacer have been damaged with evidence of deformation around the diameter of the inserter interface and on the face of the implant.Multiple witness marks on the top and bottom and the ribs of the implant have been damaged.It appears the deformation occurred when the implants were removed.This type of damage is consistent with excessive force applied to the threads of the implant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL 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: 8040809
• MDR Text Key: 127377440
• Report Number: 1030489-2018-01457
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169677715
• UDI-Public: 00643169677715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171107
• 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
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5021322
• Device Lot Number: H5402941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1