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

Model Number	75445540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographic image review single lateral xray for l3-5 fusion.Patient has a transitional type anatomy.One of the interior screws is fractured.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient with an unknown indication for posterior fixation without cage.It was reported that the screw broke post operatively.Product remains in patient.Surgery was scheduled to remove the broken screw and replace it with a similar one.Additional information received from manufacturer representative that there was no knowledge of the exact date of occurrence of screw breakage.Doctor reports that the patient had low back pain, with no apparent causative factor, 41 days after surgery, which on the following day became associated with lumbar sciatic pain and then significantly intensified.Only then did they order imaging tests and detect the broken screw.Additional surgical or medical intervention performed on (b)(6) 2021.

• 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13019009
• Report Number: 1030489-2021-01556
• Device Sequence Number: 4625337
• Product Code: KWP
• UDI-Device Identifier: 00885074134017
• UDI-Public: 00885074134017
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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 Model Number: 75445540
• Device Catalogue Number: 75445540
• Device Lot Number: H5567462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/16/2021
• Date Device Manufactured: 09/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female