Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS REDUX BLOCKER; PEDICLE SCREW SPINAL SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE-FRANCE MANTIS REDUX BLOCKER; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 48289999
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2015
Event Type  malfunction  
Event Description
It was reported that; the blockers were splaying the blades while being inserted, also, they were popping out when they hit the rod.Doctor didn't feel like these 3 blockers were working properly when trying to implant.After giving him new blockers, it went just fine.
 
Manufacturer Narrative
Lot # el9.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no anomalies were found.The returned blocker was examined and the threads were found not to have any damage evident of cross threading.Also the returned blocker was found to have no issues threading onto a polyaxial screw.Conclusion: therefore the likely cause is lack of use of the counter torque tube.
 
Event Description
It was reported that; the blockers were splaying the blades while being inserted, also, they were popping out when they hit the rod.Doctor didn't feel like these 3 blockers were working properly when trying to implant.After giving him new blockers, it went just fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MANTIS REDUX BLOCKER
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5031303
MDR Text Key25015737
Report Number0009617544-2015-00383
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48289999
Device Lot NumberEL9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-