MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 7X45MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186770445S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Cyst(s) (1800); Fever (1858); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a surgery with the vbss and prime fss was performed on (b)(6) 2024.The prime fss were inserted into the vertebral bodies above and below where the vbss were placed.Short screws were also inserted into where the vbss were placed.After the surgery, fever, infection etc.Were observed, and the implants were loose, so a removal surgery was performed on (b)(6) 2025.Since the cyst had accumulated in the psoas major muscle, debridement was also done in the removal surgery.The removal surgery was completed successfully with no surgical delay and the surgeon is keeping track of the infection condition in order to plan the next revision surgery.No further information is available.Complaints (b)(4) are related complaints.(b)(4) (synthes spine): vbs and (b)(4) (depuy spine): prime fs report about the same event occurred after the initial surgery.(b)(4) reports about the event occurred during the removal surgery.
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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME CFXFN XTB 7X45MM S
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 21275208
• Report Number: 1526439-2025-00141
• Device Sequence Number: 4045846
• Product Code: NKB
• UDI-Device Identifier: 10705034530253
• UDI-Public: (01)10705034530253
• 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: 2024
• Device Explanted Year: 2025
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 186770445S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male