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

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 PROXIMAL HUMERUS 5MM SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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 TRAUMA KIEL UNKNOWN T2 PROXIMAL HUMERUS 5MM SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
As reported: "in a case where t2ph long was used, one of the proximal screws backed out. The screw that has been backed out is the second screw from the proximal. No revision surgery planned at the moment. ".
 
Manufacturer Narrative
Device is not accessible. If additional information becomes available, it will be provided in a supplemental report. Device remains implanted in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN T2 PROXIMAL HUMERUS 5MM SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13577964
MDR Text Key285956006
Report Number0009610622-2022-00066
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
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

-
-