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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 212760
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not available.
 
Event Description
Reamer handle and end effector jammed together. Cannot be separated.
 
Manufacturer Narrative
This event was reported in error. A mdr does not need to be filed as the malfunction does not meet ccd 076 rev 2 criteria that states a mdr will be filed if there is ¿potential for serious injury due to instrument unavailability, or instrument fragments in wound site¿. The issue was noticed before the case and thus did not impact the patient or the case.
 
Event Description
Reamer handle and end effector jammed together. Cannot be separated.
 
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Brand NameOFFSET CUP REAMER HANDLE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8091405
MDR Text Key127953342
Report Number3005985723-2018-00688
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K170593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number212760
Device Lot Number3578691
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1
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