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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
Model Number 48289999
Device Problems Use of Device Problem (1670); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
Device remains in patient.
 
Event Description
It was reported that during the procedure, a mantis redux blocker was inadvertently left in the patient. An xray was performed and an additional set screw was observed. Revision is scheduled in the future.
 
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Brand NameMANTIS REDUX 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 Key11872852
MDR Text Key252331907
Report Number0009617544-2021-00088
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540671431
UDI-Public04546540671431
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48289999
Device Catalogue Number48289999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/24/2021 Patient Sequence Number: 1
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