• 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 4 LENGTH 48MM 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 4 LENGTH 48MM FOR SCREWS Ø3.5/4.0MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 430104
Device Problems Device Reprocessing Problem (1091); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2014
Event Type  Injury  
Manufacturer Narrative
This event was reported through an attorney, as a result of a legal claim. Due to the ongoing litigation no additional information is available at this time. If additional information is received it will be reported on a supplemental report.
 
Event Description
As reported: "plaintiffs allege that on or about (b)(6) 2014, (b)(6) was taken to (b)(6) hospital for treatment of injuries and fractures he sustained in a fall. Mr. (b)(6) underwent surgical treatment by surgeon for a left sub-trochanteric femur fracture and a left hip [orif]. Records from the hospital indicate that surgeon utilized a stryker. 11-hole wasted compression plate and. 4-hole recon plate during the surgery on (b)(6) 2014, when she really wanted a "proximal femoral locking plate". " surgeon "was promised a "proximal femoral locking plate" by a sales representative but when it came time to use that plate, one was not available. Instead, surgeon ended up having to use the 11-hole and the 4-hole plates. There is no allegation by plaintiffs, or the implanting surgeon, that these devices failed". A list of procedures performed on the patient identify a surgery on (b)(6) 2014 "to removed failed hardware ["failed plates x 2 with the screws"], clean infected area. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRECONSTRUCTION PLATE, STRAIGHT HOLES 4 LENGTH 48MM FOR SCREWS Ø3.5/4.0MM
Type of DevicePLATE, 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 Key7404605
MDR Text Key104657616
Report Number0008031020-2018-00283
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number430104
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
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 Treatment Data
Date Received: 04/06/2018 Patient Sequence Number: 1
-
-