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

Model Number	55751027550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of part # 55751027550, lot # h5882940 - visual and optical inspection confirmed the screw was returned broken.The break off tabs on both sides of the screw head pedicle have broken off as intended.The screw head pedicle has broken on one side and the other side is bent.The damage to the screw appears to be from bend stress overload.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 unknown spinal therapy.It was reported that the screw head was broken intra-operatively.The screw was explanted.The patient suffered a lumbar spine fracture with post-traumatic kyphosis in a traffic accident.The dorsal stabilization of bwk 11/12 to lwk 2/3 took place, using monoaxial screws for the bwk 12 and lwk 2 segments.Subsequently, a reduction (respiration and distraction) was carried out using the space t system.Underneath, the tulip of the monoaxial screw in lwk 2 bent to the left, so that the locking nut could not be inserted properly.When attempting to break off the longhead blade, the cleaning site did not break off properly.After further manipulation of the tube, it broke off.The screw was removed and replaced with a new mono axial pedicle screw.The patient did not suffer any harm as a result of this incident.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21261880
• Report Number: 1030489-2025-00432
• Device Sequence Number: 9475489
• Product Code: NKB
• UDI-Device Identifier: 00763000151249
• UDI-Public: 00763000151249
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: 55751027550
• Device Catalogue Number: 55751027550
• Device Lot Number: H5882940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: 35 YR
• Patient Sex: Female