MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC THREADED INSTRUMENTS; RETRACTOR

Model Number	897-405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of origin is france.Radiographic image review: lateral x-ray l5-s1 anterior lumbar interbody fusion (alif), a radio opaque object consistent with a stray pin is present in the l5 vertebral body.H11: 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 a healthcare provider (hcp) via manufacturer representative regarding spinal product used in anterior lumbar interbody fusion (alif) l5/s1 spinal therapy.It was reported that the distal part of the pin was broken inside the vertebra and left inside the patient.No further complications or symptoms were reported.Additional information was received via manufacturer representative that there is no revision surgery planned for removal as it is impossible to extract the broken fragment.

• Brand Name: THREADED INSTRUMENTS
• Common Device Name: RETRACTOR
• 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: 21362342
• Report Number: 1030489-2025-00743
• Device Sequence Number: 8465278
• Product Code: GAD
• UDI-Device Identifier: 00673978956541
• UDI-Public: 00673978956541
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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 Model Number: 897-405
• Device Catalogue Number: 897-405
• Device Lot Number: PZ126026
• 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: 11/29/2022
• Initial Report FDA Received Date: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown