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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7208000000
Device Problem Disassembly (1168)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 06/05/2017
Event Type  Injury  
Event Description
It was reported that the locking lever of the device fell off during a procedure.The spring could not be located.The patient received an x-ray and was treated with an antibiotic as a precaution.Additionally, it was confirmed that the x-ray came back negative.No additional adverse consequences were associated with this event.
 
Manufacturer Narrative
Investigation has been completed.
 
Event Description
It was reported that the locking lever of the device fell off during a procedure.The spring could not be located.The patient received an x-ray and was treated with an antibiotic as a precaution.Additionally, it was confirmed that the x-ray came back negative.No additional adverse consequences were associated with this event.
 
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Brand Name
SYSTEM 7 SAGITTAL SAW
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6689609
MDR Text Key79170542
Report Number0001811755-2017-01363
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7208000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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