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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48289999
Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  Injury  
Event Description
A physician reported that a patient underwent revision surgery to address a tritanium pl cage and mantis redux blocker which backed-out approximately six weeks after implantation.The patient reported experiencing leg pain prior to revision.This record captures the mantis redux blocker.
 
Manufacturer Narrative
Correction to d.10.(date): updated from 'blank' to '10/14/2019'.No issue related to the reported event was found with this product; therefore, this is a concomitant product.
 
Event Description
A physician reported that a patient underwent revision surgery to address a tritanium pl cage and mantis redux blocker which backed-out approximately six weeks after implantation.The patient reported experiencing leg pain prior to revision.This record captures the mantis redux blocker.
 
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Brand Name
MANTIS REDUX BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key9211657
MDR Text Key163038809
Report Number0009617544-2019-00117
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K092631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48289999
Device Lot Number49P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight113
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