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 CANNULATED POLYAXIAL SCREW 6.5 X 45 MM; IMPLANT-LUMBAR SCREW
  • 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 CANNULATED POLYAXIAL SCREW 6.5 X 45 MM; IMPLANT-LUMBAR SCREW Back to Search Results
Catalog Number 48285645
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2013
Event Type  malfunction  
Event Description
It was reported that during surgery, the surgeon inserted a polyaxial screw, the surgeon found a fragment of the screw head.The surgeon removed the fragment (tab piece) and completed the procedure successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM
Type of Device
IMPLANT-LUMBAR SCREW
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
daniel roberts
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key3557168
MDR Text Key4055059
Report Number0009617544-2014-00009
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K061813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48285645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2013
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2013
Initial Date FDA Received01/07/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age61 YR
-
-