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

Catalog Number	55840006550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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 underwent fusion surgery at t10 and t11 levels.Post-operatively, the set screws slide out of screws and were embedded in tissue.Hence, a revision surgery was performed, wherein the set screw was completely explanted.T10 and t11 were completely fused at time of revision surgery.The patient achieved solid fusion and experienced pain due to this surgery.
Additional Manufacturer Narrative
Product analysis results: the face of the setscrews and the saddle of the bone screw have such a heavy amount of damage from the movement of the rod in between the two components that a root cause of the failure cannot be determined.Most of the outer edge of all four setscrews have witness marks on them.This is usually consistent with angulation of the rod however since it appears that the screws backed out over time this may have just been the result of the screws backing out.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: 8406671
• Report Number: 1030489-2019-00253
• Device Sequence Number: 10826201
• Product Code: KWP
• UDI-Device Identifier: 00613994971760
• UDI-Public: 00613994971760
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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 Catalogue Number: 55840006550
• Device Lot Number: H5146904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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