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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10); PLATE, FIXATION, BONE

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STRYKER GMBH POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10); PLATE, FIXATION, BONE Back to Search Results
Catalog Number 626752S
Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
 
Event Description
We were fusing the navicular-cuneiform joint.Initially placed a 4.0 mm screw through the joint then use the nc plate over the top.We placed the proximal screws on navicular then went to use the compression rap with a 3.5 mm non locking screw.As we were screwing it in the head of the screw fell completely through the plate.This forced us to remove the construct & start over again, weakening the compression across the arthrodesis site.We placed the plate on again and then closed the case.In post op the doctor noticed unusual movement in the foot and realized our construct had fallen apart.We went in again for surgery the next day using a 5.0 inner frag, bigger plate & external fixation on top.
 
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Brand Name
POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10)
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5990390
MDR Text Key56036230
Report Number0008031020-2016-00493
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140376
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 09/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue Number626752S
Device Lot NumberF19946
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2016
Initial Date FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2014
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 Outcome(s) Required Intervention;
Patient Age57 YR
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