• 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 RECONSTRUCTION PLATE, STRAIGHT HOLES 6 LENGTH 72MM FOR SCREWS Ø3.5/4.0MM; 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 RECONSTRUCTION PLATE, STRAIGHT HOLES 6 LENGTH 72MM FOR SCREWS Ø3.5/4.0MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 430106
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
 
Event Description
The customer reported that the surgeon implanted a recon plate instead of a waisted compression plate into the wrist of a patient.The items are positioned in similar places on the small fragment set tray and have a similar appearance when viewed side by side and as such the wrong plate was handed to the surgeon in error.Indication for the primary surgery: both bone mid/distal 1/3rd forearm fracture (right) fracture not united but in reasonable alignment at 10 weeks.Significant risk of requiring revision.Under review.430106 implanted instead of 430006.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RECONSTRUCTION PLATE, STRAIGHT HOLES 6 LENGTH 72MM FOR SCREWS Ø3.5/4.0MM
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8084080
MDR Text Key127552079
Report Number0008031020-2018-00985
Device Sequence Number1
Product Code HRS
UDI-Device Identifier04546540368447
UDI-Public04546540368447
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K000636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2018
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? No
Device Operator Lay User/Patient
Device Catalogue Number430106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2018
Initial Date FDA Received11/19/2018
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
Patient Outcome(s) Other;
Patient Age48 YR
-
-