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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L415MM; PLATE, FIXATION, BONE
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STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L415MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627650S
Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Code Available (3191)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported that the patient was implanted with an axsos plate and screws approximately 1 year ago.The patient also had an expandable (non-stryker) plate implanted.This expandable plate stopped working, so the surgeon decided to revise and upon x-ray ((b)(6) 2019) he noticed that 3 axsos locking screws had backed out of the plate.The patient was revised because of the expandable plate, not the stryker locking screws.
 
Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
The customer reported that the patient was implanted with an axsos plate and screws approximately 1 year ago.The patient also had an expandable (non-stryker) plate implanted.This expandable plate stopped working, so the surgeon decided to revise and upon x-ray ((b)(6) 2019) he noticed that 3 axsos locking screws had backed out of the plate.The patient was revised because of the expandable plate, not the stryker locking screws.
 
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Brand Name
DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L415MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8731036
MDR Text Key149120335
Report Number0008031020-2019-00728
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327005295
UDI-Public07613327005295
Combination Product (y/n)N
PMA/PMN Number
K181091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number627650S
Device Lot NumberL04286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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