MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNID PATIENT SPECIFIC IMPLANTS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	B33226099-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 t10-pelvis posterior fixation and fusion procedure, with l2/l5 laminectomy and l5/s1 tlif for indication of stenosis, back pain, and sagittal imbalance.It was reported that the surgeon was bending the unid rod with in situ benders to seat the rod into a lower lumbar screw, and rod broke during this maneuver.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h3.Device evaluation summary: product analysis #(b)(4): part # b33226099-02 lot # 0231332350 visual inspection confirmed the rod was returned broken.Optical inspection revealed some wear and indentions on it from the seating and tightening of the set screw.Macroscopic inspection of the fracture surface revealed material smearing and very rigid fracture surface.The ends may have been cut during the removal process.After implant review there were no signs of preexisting damage/cracks that could contribute to the rod breaking.The rod breakage appears to from overload.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.

• Brand Name: UNID PATIENT SPECIFIC IMPLANTS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 22165067
• Report Number: 1030489-2025-02170
• Device Sequence Number: 9200099
• Product Code: KWP
• UDI-Device Identifier: 03613720289739
• UDI-Public: 03613720289739
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: B33226099-02
• Device Catalogue Number: B33226099-02
• Device Lot Number: 0231332350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 118 KG