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
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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: 8040809
• Report Number: 1030489-2018-01457
• Device Sequence Number: 19147886
• Product Code: MAX
• UDI-Device Identifier: 00643169677715
• UDI-Public: 00643169677715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2026
• Device Catalogue Number: 5021322
• Device Lot Number: H5402941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1