MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X45; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	199723745S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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.Procode: kwq and nkb.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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 a spinal fusion (t10 to l1) for the vertebral body fracture on (b)(6) 2022.The cement was injected into t10 and l1 through the screw.The surgery was completed successfully without any surgical delay.A few weeks after surgery, the l1 screw and the cement had separated.The screw was loosened inside of the vertebral body.On (b)(6) 2023, the revision surgery (t10 to l3) was performed.According to the surgeon, the screw and the cement were separated, and the patient was infected.The surgeon guessed that loss of vertebral fusion occurred due to infection, and it may cause loosening.Crp is high; however, it is unknown if infection is the cause.*remarks: (b)(4) and (b)(4) are involved with the same event.(b)(4) (depuy spine): screw.(b)(4) (synthes spine): cement.This report is for one (1) 5.5 exp verse fen scr 7.0x45.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X45
• 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: 16327263
• Report Number: 1526439-2023-00202
• Device Sequence Number: 8583387
• Product Code: KWP
• UDI-Device Identifier: 10705034444505
• UDI-Public: (01)10705034444505
• 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,Company Representative
• Initial Reporter Occupation: Other
• 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: 199723745S
• Device Catalogue Number: 199723745S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male