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

Model Number	55850016545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 55850016545, serial/lot #: (b)(6), ubd: , udi#: (b)(4).; product id: 55850016545, serial/lot #: (b)(6), ubd: , udi#: (b)(4).; product id: 55850016545, serial/lot #: (b)(6), ubd: , udi#: (b)(4).G2: country of origin - united kingdom h3: product analysis: 55850016545; lot# h5615216 visual review confirms screw breakage approximately 3 threads down from the base of the bone screw neck.Visual and microscopic examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Significant fracture surface damage.Microscopic examination of the undamaged portions of the fracture surface identified a fairly flat fracture surface with some indication of multiple ratchet marks near the area of crack propagation, and gently convex progressive striations through the cross-sectional area of the bone screw.This type of damage is consistent with cyclic fatigue.Product analysis: 55850016545 lot# h5798686 - visual examination of the mas bone screw confirmed bone screw complete fracture at a pproximately ~3 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently cu rving convex striations through the cross-sectional area of the implant, which is consistent with overload until subsequent mechanical failure of the implant.Product analysis: 55850016545 lot# h5615216 - visual examination of the mas bone screw confirmed bone screw complete fracture at a pproximately ~3 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently cu rving convex striations through the cross-sectional area of the implant, which is consistent with overload until subsequent mechanical failure of the implant.Product analysis: 55850016545 lot# h5814292 - visual examination of the mas bone screw confirmed bone screw complete fracture at a pproximately ~3 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently cu rving convex striations through the cross-sectional area of the implant, which is consistent with overload until subsequent mechanical failure of the implant.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 devices used in fusion therapy.It was reported that screw shank completely sheared, tulip and upper portion of shank detached.Implants were part of an existing construct from a previous procedure, this did not occur during the course of the operation, they were discovered in the described condition.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that previous procedure was a l5/s1 posterior fixation.Ongoing procedure was scheduled to be a decompression and revision +/- extension of existing construct.This was not due to malfunction of the product, this was discovered intra-op.Patient was experiencing pain and required decompression and revision +/- extension of existing construct.

• 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: 21304296
• Report Number: 1030489-2025-00588
• Device Sequence Number: 12823015
• Product Code: NKB
• UDI-Device Identifier: 00643169768277
• UDI-Public: 00643169768277
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170679
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: 55850016545
• Device Catalogue Number: 55850016545
• Device Lot Number: H5615216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2020
• 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: 44 YR
• Patient Sex: Unknown