MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	1556000500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure or technique used: scoliosis correction levels implanted: t10 - s1 it was reported that post-op, the product broke.Revision surgery occurred and the product was substituted.
Additional Manufacturer Narrative
Additional information: image review: post-op, xray for t10-s1, fusion show a fractured rod.The patient has an extremely flat lumbar and thoracic spine although appears to be out of sagittal balance.The bio mechanical stress +/- failure of the fusion likely constituted to rod fracture.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: no immediately adjacent pre-existing surface defects identified that could contribute to crack propagation.Fracture surface examination of the fractured rods identified ratchet marks near the origin of crack propagation, with progressive striations or beach marks emanating through the cross section of the rods until subsequent mechanical failure.Dimensional inspection confirms conformance to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with failure due to cyclic fatigue.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TSRH SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7603326
• Report Number: 1030489-2018-00847
• Device Sequence Number: 1383270
• Product Code: KWP
• UDI-Device Identifier: 00613994789914
• UDI-Public: 00613994789914
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111942
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2018

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: 1556000500
• Device Lot Number: 0436092W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/29/2018; 08/16/2018; 08/08/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/27/2018; 09/05/2018; 10/02/2018
• 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: 51 YR
• Patient Weight: 75