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

Catalog Number	8115539
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
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
It was reported that the patient was pre-operatively diagnosed with 1) lumbar 5 spondylolysis.2) l3 -l4 vertebral endplate inflammation.3) lumbar 3, 4, 5 sacral vertebral disc herniation on and underwent pedicle screw fixation.Intra-op, when the doctor was tightening the screw of the cross-link, it broke.The doctor heard the broken sound when he used a screw driver to lock, and felt the screw was no longer rotating.Product came in contact with the patient.No fragment of the implant remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examinations were performed.The tip of one of the cross-link locking screws has fractured.A microscopic review of the fracture face gives an indication that there was a side load placed on the tip of the screw causing it to fracture as the screw was tightened.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: 7364874
• Report Number: 1030489-2018-00442
• Device Sequence Number: 19346116
• Product Code: KWP
• UDI-Device Identifier: 00721902729690
• UDI-Public: 00721902729690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030840
• 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,foreig
• 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: 8115539
• Device Lot Number: 0555259W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 03/23/2018
• 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: 40 YR