MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM

Catalog Number	55840009590
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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 underwent decompression and fusion at l3-pelvis.This was a revision to a prior surgery.Intra-op, the screw head became locked.The head could not move multi-axially; and could not connect to the construct.Hence, the screw was removed and was replaced with a new one.Reportedly, the alleged screw broke as well, but no broken fragments remained inside patient's body.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection did not reveal any damage to the head or the threads of the screw.The crown of the screw has some witness marks and has been worn from the seating of the rod.Functional inspection confirmed the screw head was able to pivot in all directions.The screw appears to function as intended.No fault found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9603745
• Report Number: 1030489-2020-00086
• Device Sequence Number: 2139538
• Product Code: NKB
• UDI-Device Identifier: 00643169005327
• UDI-Public: 00643169005327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 55840009590
• Device Lot Number: H5504197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1