MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER T27 ILIAC SCREW 8X80, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	179706880
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 set screw (part # 179702000, lot # unknown, quantity # 2).This report is for one (1) viper t27 iliac screw 8x80, ti.This is report 8 of 8 for (b)(4).
Event or Problem 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).
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.B5, d10 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.

• Brand Name: VIPER T27 ILIAC SCREW 8X80, TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10891676
• Report Number: 1526439-2020-02263
• Device Sequence Number: 11576782
• Product Code: NKB
• UDI-Device Identifier: 10705034266442
• UDI-Public: 10705034266442
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 179706880
• Device Catalogue Number: 179706880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention