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

Model Number	86946540
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient for unknown spinal therapy.It was reported that the rod has slipped.There was patient involved in the event and no further complications were reported.Additional information was received on 2020-aug-14: after the universal screw placement, the rod and the screw plug were put on, and there appeared slipped between the screw plug and the screw wall, leading to unable to fix after the plug was broken, and the rod fell off from the screw slot after the surgery.The second surgery was performed, the slipped screw and screw cap were removed and the screw was re-implanted.This is a post-op event.

• Brand Name: CD HORIZON
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10464050
• Report Number: 1030489-2020-01163
• Device Sequence Number: 3001389
• Product Code: KWP
• UDI-Device Identifier: 00885074171067
• UDI-Public: 00885074171067
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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 Model Number: 86946540
• Device Catalogue Number: 86946540
• Device Lot Number: 0469730W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/28/2020
• 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
• Patient Age: 58 YR