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

Model Number	199721745
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 3 of 4 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12225036
• Report Number: 1526439-2021-01516
• Device Sequence Number: 19897374
• Product Code: NKB
• UDI-Device Identifier: 10705034442105
• UDI-Public: 10705034442105
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 199721745
• Device Catalogue Number: 199721745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR