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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279734000N
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/20/2022
Event Type  Injury  
Manufacturer Narrative
The subject device has been received, the investigation is in progress, 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 during posterior spinal fusion procedure, while placing a viper xtab screw in lumbar pedicles l5 and l4. The tips of both kick 2d brainlab screwdrivers sheared off. Attempt was made to remove sheared off tips but both were embedded inside the internal hex of the screw. Rod could lay flush and tighten down completely so surgeon made decision to leave the screws in as patient had hard bone and surgeon did not want to risk fracturing a pedicle while trying to remove. There was a surgical delay of thirty (30) minutes. The procedure was successfully completed. This report is for one (1) 5. 5 viper univ poly driver. This is report 2 of 2 for complaint (b)(4).
 
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Brand Name5.5 VIPER UNIV POLY DRIVER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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 Key13559567
MDR Text Key285831008
Report Number1526439-2022-00246
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279734000N
Device Catalogue Number279734000N
Device Lot NumberGM5358808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2019
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: 02/18/2022 Patient Sequence Number: 1
Treatment
UNK - MONO/POLYAXIAL SCREWS: VIPER; UNK - RODS: VIPER
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