MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	54840004540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer via a healthcare professional (hcp)/ medtronic representative regarding a patient implanted with spinal product in a laminectomy/fusion surgery at l4-5.It was reported that one of the screws ended up snapping and the patient had to have a second surgery on (b)(6) 2021 where they removed the previous hardware and replaced it with rods, mas screws, set screws, and bone screws (mdt products).The date of initial surgery was (b)(6) 2020.As a result of the second surgery, the patient developed a hernia and had to be hospitalized on for a hernia repair on (b)(6) 2021.As a result of the hernia repair surgery, the patient developed an infection.The patient was discharged from the hospital on (b)(6) 2021.The patient is in pain.The date of implant was (b)(6) 2020 and date of explant was (b)(6) 2021.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 12818108
• Report Number: 1030489-2021-01391
• Device Sequence Number: 4957499
• Product Code: NKB
• UDI-Device Identifier: 00613994589576
• UDI-Public: 00613994589576
• Combination Product (Y/N): N
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 54840004540
• Device Catalogue Number: 54840004540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• 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: Unknown