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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATED SERRATO TAP 5.0MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER SPINE-US NAVIGATED SERRATO TAP 5.0MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 48260250
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2018
Event Type  Injury  
Event Description
It was reported that during an l4/5 plif, upon insertion of pedicle screw into l4 vertebral body, the pedicle root broke.It was also reported that the pedicle was deformed due to degenerative scoliosis.There was no reported issue with the device.
 
Manufacturer Narrative
Corrected data: catalog number was corrected.Method: labeling review, risk assessment.The device was not returned, and a lot number was not provided, therefore no further inspection/evaluation of the device could be performed.According to the surgical technique guide, "for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended." the most likely root cause is under-tapping of the screw hole, causing excess torque that fractured the pedicle.The patient's preexisting condition may have also contributed to the event.As the device was not returned, a definitive root cause could not be determined.Device not returned.
 
Event Description
It was reported that during an l4/5 plif, upon insertion of pedicle screw into l4 vertebral body, the pedicle root broke.It was also reported that the pedicle was deformed due to degenerative scoliosis.There was no reported issue with the device.
 
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Brand Name
NAVIGATED SERRATO TAP 5.0MM
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7879027
MDR Text Key120380522
Report Number0009617544-2018-00222
Device Sequence Number1
Product Code OLO
UDI-Device Identifier07613327353051
UDI-Public07613327353051
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number48260250
Was Device Available for Evaluation? No
Date Manufacturer Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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