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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209063
Device Problems Difficult or Delayed Positioning (1157); Intermittent Loss of Power (4016)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.
 
Event Description
Submitted a prior complaint for this particular case. Post op xray's showed notching in the anterior femur. Surgeon would like to know what the cause of this was. Case type: tka. Surgical delay:
=
15 minutes.
 
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Brand NameHANDPIECE MICS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9578363
MDR Text Key177571963
Report Number3005985723-2020-00024
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42011015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
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: 01/10/2020 Patient Sequence Number: 1
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