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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR101209
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2020
Event Type  Injury  
Event Description
It was reported that during bone removal in a navio ukr procedure, the anspach drill was not able to retain the bur into the chuck. The surgery was converted to manual procedure with a delay of 15 minutes. No other complications were reported.
 
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Brand NameANSPACH EMAX 2 PLUS HAND PIECE - ROHS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10875181
MDR Text Key217323555
Report Number3010266064-2020-02019
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR101209
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/20/2020 Patient Sequence Number: 1
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