MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 7X40MM S; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	186770440S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
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.H10 additional narrative: d2b: additional product codes: nkb and kwq 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.Product was not returned.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
Device report from synthes reports an event in japan as follows: it was reported that this was an unknown surgery (l1) for burst fracture of lumbar vertebra on (b)(6) 2023.In the surgery, a balloon was inserted to l1, the prime fenestrated screws were inserted to th12 and l2.1.0 cc of the cement was injected to th12.Immediately after surgery, the cement at th12 was found to be injected in a slight unusual condition, and ct was taken on (b)(6) 2023.It was confirmed that the prime fenestrated screw at th12 protruded outward from vertebral body, and the cement leaked out of vertebral body.The surgeon judged there was no particular problem on this event because the patient¿s condition remains unchanged, and the prime fenestrated screw at th12 has a proper fixity.No further information is available.Remarks: (b)(4) are involved with the same event.(b)(4) (synthes spine): cement.(b)(4) (depuy spine): screw.This report is for one (1) viper prime cfxfn xtb 7x40mm s this is report 1 of 1 for complaint (b)(4).

• Brand Name: VIPER PRIME CFXFN XTB 7X40MM S
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 16806089
• Report Number: 1526439-2023-00734
• Device Sequence Number: 17937073
• Product Code: KWP
• UDI-Device Identifier: 10705034530246
• UDI-Public: (01)10705034530246
• 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
• 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 Model Number: 186770440S
• Device Catalogue Number: 186770440S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/25/2023
• 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
• Patient Sex: Unknown