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

Catalog Number	8115516
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
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: patient resumed for definitive arthrodesis, presence of metallosis at the level of the crosslink procedure: dismantling of the crosslink and cleaning of the metalloses and bacteriological and pathological samples it was reported that the patient underwent an unspecified surgery on an unknown date.Post-op, the crosslink was found disassembled in situ on the right side of the patient such that the right screw got detached from the crosslink.Surgical resumption for definitive arthrodesis was performed as a result of the event.The device did not break.Patient complication were reported as unknown.

• 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: 7817780
• Report Number: 1030489-2018-01168
• Device Sequence Number: 16728353
• Product Code: KWP
• UDI-Device Identifier: 00721902729355
• UDI-Public: 00721902729355
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030840
• 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
• Report Date (Section B): 08/27/2018

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: 8115516
• Device Lot Number: 0256608W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/27/2018
• 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: Required Intervention