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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (24.8 X 0.88 X 73.8MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (24.8 X 0.88 X 73.8MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number 2108105000
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, foreign material was identified in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
E1:initial reporter updated to health care professional.H6: the device was not returned for investigation.The quality investigation is complete.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, foreign material was identified in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
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Brand Name
2108 SERIES SAGITTAL BLADE (24.8 X 0.88 X 73.8MM)
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9495192
MDR Text Key175733459
Report Number0001811755-2019-04089
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540042019
UDI-Public04546540042019
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2108105000
Device Catalogue Number2108105000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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