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

Catalog Number	869-021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2018
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 r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: fracture type of procedure or technique used: fixation levels implanted: th5-th11 it was reported that post-op, rods were broken inside the patient.Patient complained of strange sound after one month of the surgery.Revision surgery was performed to remove both of the rods.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
X-ray review results: post-op x-ray for thoracolumbar posterior spinal instrumentation shows a bilateral rod fracture at the thoracolumbar transition.Time of implantation is unknown, deformity correction degree is unknown, fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the rod was returned in four sections in between 8cm and 9cm long.The rods were labeled a through d with a and b being a pair and c and d being a pair.A visual analysis of the outside diameter of the rod shows the breaks happened adjacent to the bone screw location.Both of the breaks occurred just past where the rod was bent for implantation.A microscopic review of the fracture surface indicates that both rods have similar failure modes.Both fracture surfaces have beach marks consistent with cyclic fatigue about 1/3 of the way through the fracture surface starting at the crack initiation point.Both of the rods have a steep double shear lip at the end of the fracture that is consistent with a fast-moving fracture.For the amount of time that the rods were implanted it is possible given the location of the fracture in relation to the angle of the bend that the rod was preloaded.This could increase the effect of the cyclic movements.Once the rod had lost cross-sectional strength form the cyclic movements the fracture increase d in speed suddenly causing the shear lips at the end of the fracture.The outside diameter of the rod meets print spec.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8237610
• Report Number: 1030489-2019-00044
• Device Sequence Number: 13859176
• Product Code: KWP
• UDI-Device Identifier: 00885074046600
• UDI-Public: 00885074046600
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2019

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: 869-021
• Device Lot Number: 0545883W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 05/09/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/24/2019; 06/03/2019
• 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: 14 YR
• Patient Weight: 45