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

Catalog Number	55840014540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision surgery, pseudoarthrosis.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.Image review: post-op ct shows fracture of l2 screw at gear point following stabilization of an l1 burst fracture.Operation notes were not provided, but no bony arthrodesis was performed.This is the expected result after short segment stabilization of a spinal segment.
Event or Problem Description
It was reported that on (b)(6) 2014, patient underwent fracture bracing surgery due to l1 burst fracture at levels t12- l2.Post-op, screws broke.Patient did not achieve fusion as broken screws lead to mobile site.No fragments remained inside the patient.Patient underwent revision surgery for the removal of broken screws.Screws ex planted completely.Right in the middle of the screw thread broke.
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: 6568558
• Report Number: 1030489-2017-01239
• Device Sequence Number: 75068
• Product Code: KWP
• UDI-Device Identifier: 00643169076860
• UDI-Public: 00643169076860
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55840014540
• Device Lot Number: 0259847W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 61