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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NON STRYKER PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO NON STRYKER PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problems Abrasion (1689); Not Applicable (3189)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not available for return.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional durotomy involving damage to the meninges during a bur hole as a result of this event.No further information was provided.
 
Manufacturer Narrative
Follow up with the customer in this event confirmed that no stryker product was involved in this event.The event involved a non-stryker product a adeor blade adeor, lot; unknown, manufactured by imc impomed.A letter was be sent to imc impomed notifying them of the event and also the fda.As a result the event is considered an inquiry.No stryker product was involved.: non stryker device.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional durotomy involving damage to the meninges during a bur hole as a result of this event.No further information was provided.Update; sales rep advised that no stryker device was involved in this event.No malfunction reported involving a stryker device.The device involved was a blade adeor, lot; unknown, imc impomed device.A letter will be sent to imc impomed notifying them of the event and also the fda.As a result this stryker complaint will be cancelled.As a result the event is considered an inquiry.No stryker product was involved.
 
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Brand Name
NON STRYKER PRODUCT
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9505816
MDR Text Key172284750
Report Number0001811755-2019-04147
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540716224
UDI-Public04546540716224
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100060001
Device Catalogue NumberNON STRYKER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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