MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 5.0X40; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723540S

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that on (b)(6) 2020 the patient had loosening of screws and required a re-arthrodesis.All screws were successfully removed from left/right - l3, l4, l5, s1, il.There was a five (5) minute surgical delay and procedure outcome was unknown.There was no patient harm/consequence.Concomitant devices: expedium 5.5mm titanium rods(part # unknown, lot # unknown, quantity # 2).5.5 exp verse unitized set scr (part # 199721001, lot # unknown, quantity # 8).Single-inner setscrew (part # 179702000, lot # unknown, quantity # 2).This report is for one (1) 5.5 exp verse fen scr 5.0x40.This is report 2 of 8 for (b)(4).

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 Description

Updated concomitant device reported: expedium 5.5mm titanium rods (part: unknown, lot: unknown, quantity 2); 5.5 exp verse unitized set screw (part: 199721001, lot: unknown, quantity 8); single-inner setscrew (part: 179702000, lot: unknown, quantity 2); 5.5 exp verse fen screw 7.0x40 (part: 199723740s, lot: unknown, quantity 2).

• Brand Name: 5.5 EXP VERSE FEN SCR 5.0X40
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10890130
• MDR Text Key: 217954586
• Report Number: 1526439-2020-02257
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443317
• UDI-Public: 10705034443317
• Combination Product (y/n): N
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199723540S
• Device Catalogue Number: 199723540S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 5.0X40.; 5.5 EXP VERSE FEN SCR 7.0X40.; 5.5 EXP VERSE FEN SCR 7.0X40.; 5.5 EXP VERSE UNITIZED SET SCR.; EXPEDIUM 5.5MM TITANIUM RODS.; SINGLE-INNER SETSCREW.; VIPER T27 ILIAC SCREW 8X80, TI.; 5.5 EXP VERSE UNITIZED SET SCR; EXPEDIUM 5.5MM TITANIUM RODS; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention