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

Catalog Number	5442141
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
Pre-op diagnosis: revision laminectomy l3/4 procedure: posterior lumbar interbody fusion at l2/5 it was reported that during surgery, the inner portion of the crosslink set screw was found broken after final tightening.Crosslink, set screws and rods were replaced.No fragments remained in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual and microscopic review confirmed that the tip on one break off screw was fractured.A microscopic review of the fracture face revealed that the fracture is consistent with torsional overload with a bending moment introduced as the screw head pushed against the rod.It is noted that the broken screw had been driven down several threads deeper than the screw that is not broken.If the screw is driven deeper using the inner hex after the break-off portion of the screw head has come off, there is a chance to overload the tip of the screw.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: 7040947
• Report Number: 1030489-2017-02358
• Device Sequence Number: 1358485
• Product Code: KWP
• UDI-Device Identifier: 00613994579539
• UDI-Public: 00613994579539
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• 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): 05/25/2018

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: 5442141
• Device Lot Number: 0463542W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR