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	10/25/2018
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 t11-l3 fusion was being performed on patient with l1 burst fracture.Intra-operatively, a nut of the crosslink sheared off.The crosslink was implanted and the outer screws were broken off.When the middle nut of the crosslink was being tightened, it sheared off.Due to this, the broken crosslink was completely removed and replaced with a new one.No fragment of the broken implant remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and microscopic review confirms that both set screws have been fractured.The tip has broken off on one and on the other screw the bottom and tip have broken off.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.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.This type of damage is consistent with torsional overload.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: 8077033
• Report Number: 1030489-2018-01493
• Device Sequence Number: 215063
• Product Code: KWP
• UDI-Device Identifier: 00613994579539
• UDI-Public: 00613994579539
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/16/2019

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: 5442141
• Device Lot Number: 0446533W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR