MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723750S

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2023

Event Type  Injury  

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: only the event year and month is known.Additional device product codes: kwq, kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6).Reporter is a j&j employee.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 Description

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a posterior fusion on (b)(6) 2022.The surgery was completed successfully without any surgical delay.On (b)(6) 2022, a revision surgery was performed for an unknown reason.Mesh cage was installed in vcr area.In january, the mesh cage fell into the lower vertebral body and became unstable.The image showed that the screws were loosened.Therefore, a second revision surgery was performed.The specific date of the event is unknown, as it developed gradually.No further information is available.This report involves one expedium verse spine system fenestrated cortical fix polyaxial screw 7.0 x 50mm.This report is related to (b)(4), which reports the mesh cage.This is report 4 of 4 for (b)(4).

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM
• Type of Device: 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: 16431946
• MDR Text Key: 310136046
• Report Number: 1526439-2023-00336
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034444499
• UDI-Public: (01)10705034444499
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199723750S
• Device Catalogue Number: 199723750S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 6.0X45.; 5.5 EXP VERSE FEN SCR 6.0X45.; 5.5 EXP VERSE FEN SCR 7.0X50.; SYNMESH(TM) 17MM X 22MM 88MM HEIGHT (TI).
• Patient Outcome(s): Required Intervention
• Patient Sex: Male