MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 4.5X45; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186745445S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that initial procedure was a psf (t12/l1) for osteoporotic vertebral fracture performed on (b)(6) 2023.After surgery, the screws in question were found to be coming off and touching skin.It was also found that the screws had not been inserted into proper places i.E., not inserted into pedicles in the primary surgery.On (b)(6) 2023, a revision surgery was performed.In the revision surgery, th12/l1 left screws were replaced.Rods were bent to prevent inserting set screws to be inserted forcibly, and the surgeon completed final tightening.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) viper prime cfxfen xtab 4.5x45.This is report 2 of 2 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.D2b: additional product codes: nkb, kwp.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.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.

• Brand Name: VIPER PRIME CFXFEN XTAB 4.5X45
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 16922095
• Report Number: 1526439-2023-00834
• Device Sequence Number: 6930367
• Product Code: KWQ
• UDI-Device Identifier: 10705034529844
• UDI-Public: (01)10705034529844
• 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: 2023
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186745445S
• Device Catalogue Number: 186745445S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: VIPER PRIME CFXFEN XTAB 4.5X45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male