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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE HOLES 3 LENGTH 38MM FOR SCREWS 3.5/4.0MM; PLATE, FIXATION, BONE
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STRYKER GMBH ONE-THIRD TUBULAR PLATE HOLES 3 LENGTH 38MM FOR SCREWS 3.5/4.0MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 621123
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted in patient.
 
Event or Problem Description
It was reported that the axsos 4.0 screw passed through the center hole of the sps 1/3 tubular plate intra-operatively.The surgeon removed the screw, added a washer from the sps small fragment set, and re-implanted the screw.
 
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Brand Name
ONE-THIRD TUBULAR PLATE HOLES 3 LENGTH 38MM FOR SCREWS 3.5/4.0MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key10268333
Report Number0008031020-2020-01887
Device Sequence Number16881869
Product Code HRS
UDI-Device Identifier04546540097286
UDI-Public04546540097286
Combination Product (Y/N)N
Initial Reporter StateME
Initial Reporter CountryUS
PMA/510(K) Number
K000636
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number621123
Device Catalogue Number621123
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/17/2020
Initial Report FDA Received Date07/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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