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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER SHAFT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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DEPUY SPINE INC VIPER PRIME INSERTER SHAFT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 286750031
Device Problem Device Slipped (1584)
Patient Problems Nerve Damage (1979); Injury (2348)
Event Date 10/22/2020
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, during an unknown procedure, the viper prime inserter shaft came loose from the screw mid-insertion. It was still tight on the tower of the screw but where the inserter shaft meets the shank of the screw came loose, causing the tip of the screw to also be loose and therefore throwing off our navigation projection. The screw was removed from canal and attempted to be placed in pedicle three times. There was a surgical delay of fifteen to thirty (15 to 30) minutes. The patient was very close to having motor or sensory nerve issues due to screw being placed in the spinal canal. Multiple additional screw placements and o-arm spins are required. The procedure was successfully completed. The screw was thrown in the sharps disposables after the case by the hospital. The viper prime inserter shaft was inspected and appeared to be fine. Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity 1). This report is for one (1) viper prime inserter shaft. This is report 1 of 2 for complaint (b)(4).

 
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Brand NameVIPER PRIME INSERTER SHAFT
Type of DeviceTHORACOLUMBOSACRAL 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 Key10863973
MDR Text Key217095438
Report Number1526439-2020-02229
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number286750031
Device Catalogue Number286750031
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/18/2020 Patient Sequence Number: 1
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