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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US MANTIS BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48289999S
Device Problem Migration (4003)
Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2020
Event Type  Injury  
Event Description
A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively. The patient was revised and the physician indicated that the mantis blocker was found to have been cross-threaded in the screw during implant surgery, allowing the rod to migrate post-operatively.
 
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Brand NameMANTIS BLOCKER
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR 33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key10176480
MDR Text Key195812921
Report Number0009617544-2020-00093
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48289999S
Device Lot Number3UJ
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/19/2020 Patient Sequence Number: 1
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