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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 5.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US 5.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482615540
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that the head of a xia serrato polyaxial screw was jammed intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
A visual inspection was performed.The tulip is seated higher on the shank than intended.Tulip was confirmed to be jammed on the screw shank bulb.A mallet impact onto the proximal end of the tulip dislodged the tulip and brought it back to a normal position and its normal range of polyaxiality.A screwdriver was able to properly engage screw after the tulip was returned to a normal position.Device history records were reviewed for this lot number, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.No additional information was received from the field.The most likely cause of the reported event was determined to be due to the screw being over inserted.It is likely that during screw insertion the tulip was forced proximally on the screw shank by the bone which caused it to jam.This can occur if the screw is initially over inserted.
 
Event Description
It was reported that the head of a xia serrato polyaxial screw was jammed intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
 
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Brand Name
5.5X40 POLYAXIAL SCREW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
SZ   2300
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key13794950
MDR Text Key287333906
Report Number3005525032-2022-00008
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327351842
UDI-Public07613327351842
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number482615540
Device Catalogue Number482615540
Device Lot NumberC15073
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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