MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75446545
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
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 the patient had lumbar fracture due to which patient had to undergo lumbar fracture repair.During surgery, the screw was found slipped.It was explanted completely from the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: the inner hex of the bone screw is stripped.The treads in the head of the screw do not appear to be damaged and will pass a functional check.The threads on the bone screw shaft do not appear to be damaged.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7127998
• Report Number: 1030489-2017-02518
• Device Sequence Number: 13932292
• Product Code: KWP
• UDI-Device Identifier: 00885074134123
• UDI-Public: 00885074134123
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 75446545
• Device Lot Number: H5338881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR