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

Catalog Number	5442147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
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.
Event or Problem Description
Pre-op diagnosis: spinal stenosis procedure: posterior lumbar interbody fusion(plif) levels implanted: "1" level it was reported that during surgery, the screw broke and sheared off when the surgeon was torquing it down.The products came in contact with the patient.No fragments remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and microscopic review confirms that the tip of the break off screw was fractured.A microscopic review of the fracture face reveals that the fracture is consistent with torsional overload with a bending moment introduced as the screw head pushed against the rod.There are witness marks on both the external and internal hex.If the screw is driven down using the internal hex bypassing the torque limiting feature, it is possible to tighten the screw with enough pressure to shear the tip.There is damage to the threads on the inside of the hook consistent with high levels of force being placed on the screw tip and rod.The witness marks on the tip of the screw that was returned reveal a higher level of force than is usually seen.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: 7120368
• Report Number: 1030489-2017-02501
• Device Sequence Number: 19112446
• Product Code: KWP
• UDI-Device Identifier: 00613994588487
• UDI-Public: 00613994588487
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/01/2018

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: 5442147
• Device Lot Number: 0598422W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR