MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: mni.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 (b)(6) as follows: it was reported that on an unknown date, the surgeon stated a revision surgery is required to remove a broken pedicle screw from a patient.The original operation was completed on (b)(6) 2017.There is no further information available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown setscrew (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 5.5 exp verse fen scr 6.0x50.This is report 1 of 1 for (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.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
Concomitant devices reported: 5.5 exp verse unitized set scr (part number 199721001, lot unknown, quantity 4).Mmsi rod prebent, 5.5 x45mm (part number 179772045, lot unknown, quantity 2).5.5 exp verse fen scr 6.0x50 (part number 199723650, lot unknown, quantity 3).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10976586
• Report Number: 1526439-2020-02373
• Device Sequence Number: 19008525
• Product Code: PML
• UDI-Device Identifier: 10705034403076
• UDI-Public: (01)10705034403076
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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: 199723650
• Device Catalogue Number: 199723650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 01/28/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/05/2021; 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X50.; 5.5 EXP VERSE FEN SCR 6.0X50.; 5.5 EXP VERSE FEN SCR 6.0X50.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.; MMSI ROD PREBENT, 5.5 X45MM, T.; MMSI ROD PREBENT, 5.5 X45MM, T.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention