MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNID¿ PATIENT SPECIFIC IMPLANTS; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	B33243599-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for forward head position, cervical stenosis, neck pain radiating into right shoulder and deltoid.Patient reports, difficulty with turning his head and chronic pain, takes oxycontin 30mg three times a day with oxycodone 5mg three times a day for breakthrough pain.Patient uses lidocaine patches and not had any recent physiotherapy, injections, massage, acupuncture.It was reported that, the rod broke while surgeon was doing in situ bending.The breakage happened at the transition point, which is c7-t1 in this case.The procedure/technique performed was fusion.There were no patient symptoms reported, no additional treatment or surgery performed as a result.No further complications reported.

• Brand Name: UNID¿ PATIENT SPECIFIC IMPLANTS
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21500905
• Report Number: 1030489-2025-01058
• Device Sequence Number: 14565150
• Product Code: NKG
• UDI-Device Identifier: 03613720289999
• UDI-Public: 03613720289999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2025

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 Expiration Date: 02/14/2024
• Device Model Number: B33243599-01
• Device Catalogue Number: B33243599-01
• Device Lot Number: 0227731554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 03/02/2025
• Date Device Manufactured: 11/09/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 82 KG