MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199721745

Device Problem Device Slipped (1584)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

It was reported that on (b)(6) 2021, the surgeon revised an l4/5 fusion.The hardware (expedium verse & matrix x-link) was all losing due to infection and nonunion.One of the lock caps had come off as well.Patient and procedure outcome were unknown.This complaint involves four (4) devices.This report is for (1) 5.5 exp verse screw 7.0 x 45.This report is 4 of 4 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 45
• 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 ; 6107195000
• MDR Report Key: 12225045
• MDR Text Key: 263395967
• Report Number: 1526439-2021-01517
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442105
• UDI-Public: 10705034442105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721745
• Device Catalogue Number: 199721745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2021
• 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 SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 7.0 X 45
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR