MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE FEN SCR 6.0X40; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723640S

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 6.0x40.This is report 1 of 8 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X40
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10890033
• MDR Text Key: 217959336
• Report Number: 1526439-2020-02256
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443492
• UDI-Public: 10705034443492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 199723640S
• Device Catalogue Number: 199723640S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• 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 UNITIZED SET SCR; EXPEDIUM 5.5MM TITANIUM RODS; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention