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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).
 
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.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
Updated concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).
 
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Brand Name
VIPER PRIME INSERTER SHAFT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10863973
MDR Text Key217095438
Report Number1526439-2020-02229
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034507583
UDI-Public(01)10705034507583
Combination Product (y/n)N
PMA/PMN Number
K171570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/22/2020
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
Device Operator Health Professional
Device Model Number286750031
Device Catalogue Number286750031
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/22/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN SCREWS
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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