MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 6X50MM S; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186760450S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: d2: additional procode: kwp, kwq.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.H3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 186760450s.Lot: tbakyg.It was electronically reviewed and no nonconformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: 21-february-2023.Manufacturing site: jabil le locle.Expiry date: 31-january-2028.The product was not returned to depuy synthes; however, photos were received for review.The photo investigation revealed that the viper prime cfxfn xtb 6x50mm s has broken from the threaded tip.The breakage condition of the implant was consistent with a random component failure that may have been caused by exposure to unintended forces.No postoperative x-rays were provided to confirm the embedded device.With the limited information.The reported condition can be partially confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the viper prime cfxfn xtb 6x50mm s would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent surgery for l2 vertebral fracture on (b)(6) 2023.Th12, l1-l3, and l4 was fixed with prime fenestrated screws.The cement was used in th12 and l4 on both sides.Removal surgery was performed on (b)(6) 2024, after the confirmation of osteosynthesis.In the removal surgery, when the screw (l4) was removed, breakage was confirmed on the tip.Remnants were observed within the vertebrae in the front and side in imaging.The surgeon determined that there would be no impact on the patient because it was within the vertebral body.The surgery was completed successfully with no surgical delay.After the surgery, the surgeon commented that it was unclear whether the breakage was due to metal fatigue or an unusual force applied during the extraction operation, but it is evidence that the bone cement is working there was no patient consequence.This report is for a viper prime cfxfn xtb 6x50mm s.This is report 1 of 1 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: VIPER PRIME CFXFN XTB 6X50MM S
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19983305
• Report Number: 1526439-2024-02037
• Device Sequence Number: 15474499
• Product Code: NKB
• UDI-Device Identifier: 10705034530109
• UDI-Public: (01)10705034530109(11)230221(17)280131(10)TBAKYG
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 186760450S
• Device Lot Number: TBAKYG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - BIOMATERIAL - CEMENT
• Patient Sex: Male