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

Catalog Number	7577540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
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 intra-op, a screw broke.It was removed and replaced.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual inspection confirmed the bone screw disassembled from the head.The ring and crown were still assembled in the head.A portion of the retaining ring has been bent and sheared off.The bent/sheared section is sticking out of the bottom of the head with the remaining portion of the ring still seated in the groove of the head.Microscopic inspection confirmed witness marks inside the crown of the screw and the hex of the bone screw has been damaged.The bone screw head diameter found to be within print specification.The above observations are consistent with overload as the mechanism of failure.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 TN 46582
• MDR Report Key: 7946169
• Report Number: 1030489-2018-01333
• Device Sequence Number: 930600
• Product Code: KWP
• UDI-Device Identifier: 00885074032047
• UDI-Public: 00885074032047
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 7577540
• Device Lot Number: 0062367W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR