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

Catalog Number	X0509160
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
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
Levels implanted: l5/s1 it was reported that intra-op, the center t27 nut of the crosslink did not torque out and it was acted like it stripped.No health damage in the patient was reported.
Additional Manufacturer Narrative
Product analysis result: visual optical functional visual and optical inspection confirmed multiple witness marks along the shafts of the crossing.Functional inspection confirmed the center nut will no longer tighten the crosslink arms of the implant.It appears the center nut has been over torqued damaging the threads of the multispan eyebolt.The center nut is unable to be threaded off.This type of damage is consistent with the screw being over torqued.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: 8098368
• Report Number: 1030489-2018-01520
• Device Sequence Number: 2325549
• Product Code: KWP
• UDI-Device Identifier: 00613994648914
• UDI-Public: 00613994648914
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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 Catalogue Number: X0509160
• Device Lot Number: 0565718W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1