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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 8MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 8MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 6741608
Device Problems Fitting Problem (2183); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2017
Event Type  malfunction  
Event Description
It was reported that; during surgery, the surgeon inserted the screw without the inserter guide because the inserter guide could not be attached to a cage due to interference with the sternum.Then the screw did not lock to the plate properly.The surgeon exchanged with another screw, the second screw locked to the cage.
 
Event Description
It was reported that; during surgery, the surgeon inserted the screw without the inserter guide because the inserter guide could not be attached to a cage due to interference with the sternum.Then the screw did not lock to the plate properly.The surgeon exchanged with another screw, the second screw locked to the cage.
 
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Brand Name
ANCHOR C DIAM 3.5MM SELF DRILLING 8MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH   2300
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6621518
MDR Text Key77309440
Report Number3005525032-2017-00067
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
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 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6741608
Device Lot NumberEBK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2016
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 Age41 YR
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