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

Catalog Number	8116445
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported that on an unknown date, the patient underwent posterior lumbar interbody fusion due to lumbar degenerative disease.Intra-op, when the screw plug was screwed, it broke at the non-breaking point.The product came in contact with the patient.No fragment of the broken product remained inside the patient.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the crosslink was returned with a rod attached to it.Functional inspection confirmed the locking nut was able to be tightened and loosened.Optical inspection of one of the set screws confirmed the threaded portion of the screw was sheared/broken off and still threaded into the crosslink.The other set screw appears to be functional.It appears a hex was used to tighten the screw which caused it to break at the threads instead of using the break off driver which will cause the upper portion of the screw to break instead.This is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: 3 report source ("foreign" check box has been ticked).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: 8467916
• Report Number: 1030489-2019-00356
• Device Sequence Number: 1341578
• Product Code: KWP
• UDI-Device Identifier: 00721902819674
• UDI-Public: 00721902819674
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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: 8116445
• Device Lot Number: 0618417W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019; 05/15/2019
• Initial Report FDA Received Date: 03/30/2019
• Supplement Report FDA Received Date: 03/30/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR