MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 5X45MM S; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186750445S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.H11 additional narrative: d2b.Additional pro-codes: kwq, kwp.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 this was an unknown surgery for fracture on (b)(6) 2023.After the surgery, it was confirmed that of the eight screws, several that were not cemented had backed out, and all were to be removed.On (b)(6) 2024, the removal surgery was performed.In the surgery after the removal, the screw with cement injected found to be short and confirmed to be broken.It was confirmed that a part of the screw has remained in the body.The surgery was completed successfully with no surgical delay.The surgeon commented that there was no resistance at the time of screw removal, so it did not feel like it was broken at the time of removal.Also, he mentioned that the screw left behind in the body appears to be attached to the cement, so he doesn't think it's affected.This pc is related to (b)(4) which reports the removal surgery caused by the screw backed out after the initial surgery.This pc reports the event that a part of screw which should have been removed was left in the body due to breakage.This report is for one (1) viper prime cfxfn xtb 5x45mm s this is report 1 of 1 for complaint (b)(4).
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.H11 additional narrative: h6: component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H6: device history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 186750445s.Lot number: tbajcq.It was electronically reviewed and no nonconformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: 10-jun-2022.Manufacturing site: jabil le locle.Expiry date:30-apr-2027.Corrected data: d4: primary udi number updated.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME CFXFN XTB 5X45MM 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 Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19757387
• Report Number: 1526439-2024-01847
• Device Sequence Number: 6532589
• Product Code: NKB
• UDI-Device Identifier: 10705034529950
• UDI-Public: (01)10705034529950(17)270430(10)TBAJCQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup

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: 186750445S
• Device Lot Number: TBAJCQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2022
• 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: UNKNOWN BIOMATERIAL - CEMENT.
• Patient Age: 50 YR
• Patient Sex: Female