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	02/13/2018
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
Pre-operative diagnosis: l5- s1 degenerative disc procedure: posterior lateral interbody fusion (plif) levels implanted: l5-s1 it was reported that on (b)(6) 2018, intra-op, when physician placed a 41mm crosslink in between the screws and went to torque down the crosslink on the lateral sides, the crosslink stripped and broke into pieces.Doctor was able to obtain all the pieces of the implant from the wound.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis result: visual functional microscopic there were three adjustable cross-links returned.Two of the screws that lock the rods in place have sheered off where the threads transition into the nose of the screw.On one of the screws, deformation can be noted to the internal hex.On the other broken screw, a portion of the driver has broken off inside the internal hex.The center locking not on the three links appears to function properly.The screws appear to have been over tightened causing the nose to break off.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7337106
• Report Number: 1030489-2018-00378
• Device Sequence Number: 1483597
• Product Code: KWP
• UDI-Device Identifier: 00613994579539
• UDI-Public: 00613994579539
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 0489132W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 08/08/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 08/07/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR