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

Catalog Number	55840006540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
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.X-ray review results: post-op x-ray for l4-s1 fusion.Ap/lateral images are provided.No interbody grafts are present.Both s1 screws appear fractured.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with spondylolisthesis; and underwent lumbar fusion at l4-s1.On (b)(6) 2020, post-op, the doctor found that an implanted s1 screw had broken.The patient also experienced pain.Hence, a revision surgery was performed, in which it was found that both s1 screws (one at either side of s1) had fractured.Both the broken screws were completely explanted.The previous construct was also revised during this surgery.

• 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: 9803074
• Report Number: 1030489-2020-00281
• Device Sequence Number: 16290196
• Product Code: NKB
• UDI-Device Identifier: 00613994971746
• UDI-Public: 00613994971746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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 Catalogue Number: 55840006540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: 14 YR