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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM PLATE, FIXATION, BONE

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STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM PLATE, FIXATION, BONE Back to Search Results
Model Number 40-20807
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Limb Fracture (4518); Implant Pain (4561)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "initial procedure is (b)(6) 2020. Implanted plate. Lag screw 18mm for proximal and distal pieces. 2 fiber wires used for 3rd bone piece. 18 mm non-locking in the elliptical hole, and locking screws are used for all other holes. Postoperative rehabilitation: 4 weeks unloaded, 6 weeks full weight. The patient complained a pain on (b)(6) 2021. Proximal locking rupture + plate deflection were occurred on (b)(6) 2021. Broken the plate were occurred on (b)(6) 2021. The patient underwent a revision surgery. ".
 
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Brand NameSTRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12582857
MDR Text Key274926319
Report Number0008031020-2021-00432
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number40-20807
Device Catalogue Number4020807S
Device Lot NumberG15551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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