• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 10 HOLE / L238MM PLATE, FIXATION, BONE

  • 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 GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 10 HOLE / L238MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627610
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544); Implant Pain (4561)
Event Date 10/25/2018
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report. Device disposition is unknown.
 
Event Description
The regional counsel (b)(6) reported to stryker a case from 2018 (legal involved). It is written: "patient operated on (b)(6) 2019 for hypertrophic pseudarthrosis of the distal left femur on a ptg. Immediate follow-up was straightforward. The patient presented with a plate rupture without any notion of particular trauma. Immediate functional impotence. Pain on mobilization. Radiographs: rupture of the plate under the proximal screws. Persistence of the fracture line. Removal of the axsos plate 27642 and 27610".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 10 HOLE / L238MM
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12632487
MDR Text Key276454278
Report Number0008031020-2021-00436
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K200398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number627610
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
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 Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
-
-