• 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 LAG SCREW, TI GAMMA3® Ø10.5X90MM 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 LAG SCREW, TI GAMMA3® Ø10.5X90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30600090S
Device Problems Break (1069); Material Separation (1562)
Patient Problems Fall (1848); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Date 12/17/2015
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
It was reported that patient had a gamma nail implanted 2 years ago in their left leg. Patient stated that after 6 months, their surgical site was less than 20% healed and that the gamma screw had separated and the pin at the bottom broke. Not revised, started causing pain approximately 2 to 3 months ago and patient wants to know if any of the devices were recalled. Patient additionally reported that she kept falling and having trouble with it. Felt like it was coming out the side of her thigh. Has a funny gait, does not walk right. For a while it was not hurting. Staring a month ago, it started to burn again.
 
Manufacturer Narrative
Investigation summary: received x-ray identified item not at fault. It did not contribute to locking screw breakage. Thus, concomitant item.
 
Event Description
It was reported that patient had a gamma nail implanted 2 years ago in their left leg. Patient stated that after 6 months, their surgical site was less than 20% healed and that the gamma screw had separated and the pin at the bottom broke. Not revised, started causing pain approximately 2 to 3 months ago and patient wants to know if any of the devices were recalled. Patient additionally reported that she kept falling and having trouble with it. Felt like it was coming out the side of her thigh. Has a funny gait, does not walk right. For a while it was not hurting. Staring a month ago, it started to burn again.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLAG SCREW, TI GAMMA3® Ø10.5X90MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5441218
MDR Text Key38329561
Report Number0009610622-2016-00060
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2018
Device Catalogue Number30600090S
Device Lot NumberK03EC6C
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 Received03/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
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: 02/17/2016 Patient Sequence Number: 1
-
-