MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	83565508
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post-op x-rays shows thoracic lumbar sacral posterior spinal instrumentation.Interbody graft are present at l5-s1, l4-5, l3-4.The patient body "condition" is quite obese.On the immediate post-op x-ray hardware placement appears appropriate.On the delayed x-ray there is a bilateral rod fracture, with the rod completely displaced from the screw heads on one side.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with degenerative scoliosis with multilevel stenosis, degenerative disc disease (ddd) and underwent multilevel laminectomy fusion surgery at t11- ileum levels.Post-operatively, the screw loosened.As a result, a revision surgery was performed to remove the alleged screw.No patient complications were reported post surgery.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the pin of the bone screw is not seated fully inside the joint of the screw.There is no thread damage nor surface damage.Unable to determine root cause of pin backing out.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TSRH SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8255679
• Report Number: 1030489-2019-00065
• Device Sequence Number: 13943075
• Product Code: NKB
• UDI-Device Identifier: 00613994568502
• UDI-Public: 00613994568502
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K092676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Catalogue Number: 83565508
• Device Lot Number: 0062844W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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: Required Intervention
• Patient Age: 66 YR