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

Catalog Number	8115545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: visual and macroscopic examination confirmed that the crosslink middle hex set screw is stripped and jammed.There are numerous witness marks across the rods of the crosslink indicating use.The two locking screws have been tightened down and the hex appears to be stripped as well.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on an unknown date, post-op, the screw broke.The patient underwent revision surgery for removal of the screw.Crosslink was also explanted in this revision surgery; for which no malfunction was reported.No fragments of the screw remained inside the patient.The patient had not achieved solid fusion.No patient complications have been reported after the revision surgery.

• 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: 8324831
• Report Number: 1030489-2019-00131
• Device Sequence Number: 2253666
• Product Code: KWP
• UDI-Device Identifier: 00721902729713
• UDI-Public: 00721902729713
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 8115545
• Device Lot Number: 0592982W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/11/2019
• 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: 60 YR
• Patient Weight: 92