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 REDUCTION SCREW 7.5 X 35MM; IMPLANT- THORACO/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 REDUX REDUCTION SCREW 7.5 X 35MM; IMPLANT- THORACO/LUMBAR SCREW Back to Search Results
Catalog Number 48289735
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2014
Event Type  malfunction  
Event Description
It was reported that during reduction, when tightening the nut after distraction, the nut had no grip onto the tulip of the screw and the nut turned in the air.The surgeon has therefore removed the nut, removed the stem and changed the mantis screw.The removed screw was discarded.
 
Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the tulip of a mantis redux reduction screw 7.5 x 35mm was reported to have splayed while trying to insert a blocker during a l4-s1 arthrodesis.The surgeon was unable to get the blocker to engage the threading of the screw head and then had to remove the screw to find the abovementioned damage of the tulip.The reported issue caused a 15 minute surgical delay, but did not have any adverse consequences to the patient.The screw, which was discarded at the hospital, was either lot 13a313 or lot 128754.A review of both lots manufacturing records did not reveal any production issues.It is unknown whether the damage to the tulip occurred while inserting the blocker or at some point prior to that step in the surgery.It is possible that the damage occurred during distraction of the construct, which required direct, outward loading of the screw-heads.The cause of the issue was not determined.Conclusion: because the device has not been returned the exact cause of the event cannot be determined and is likely multifactorial.
 
Event Description
It was reported that during reduction, when tightening the nut after distraction, the nut had no grip onto the tulip of the screw and the nut turned in the air.The surgeon has therefore removed the nut, removed the stem and changed the mantis screw.The removed screw was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MANTIS REDUX REDUCTION SCREW 7.5 X 35MM
Type of Device
IMPLANT- THORACO/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 Key3792054
MDR Text Key21177391
Report Number0009617544-2014-00206
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K102235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48289735
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2014
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 Sequence Number1
-
-