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

Model Number	5440430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2018
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 the patient was pre-operatively diagnosed with spine degeneration and underwent surgery at the l4-l5 level.During surgery, the cap of the break off set screw would not break off.On direct visualization it was seen that the cap had broken and bent up the side of the cap and not directly off of the threaded portion.The product came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis visual and optical inspection confirmed the break off portion of the screw was returned cracked and deformed.The threaded portion was not returned for analysis.It appears the break off portion was damaged during the break off process.This type of damage is consistent with bend stress overload.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: 7636639
• Report Number: 1030489-2018-00901
• Device Sequence Number: 4269357
• Product Code: KWP
• UDI-Device Identifier: 00613994790729
• UDI-Public: 00613994790729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Model Number: 5440430
• Device Catalogue Number: 5440430
• Device Lot Number: H5396039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1