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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 212186
Device Problems Device Reprocessing Problem (1091); Fracture (1260); Contamination /Decontamination Problem (2895); Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
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
Seal broken on saw attachment. Fluid leaked out. Case type: tka. Surgical delay: 15 minutes. Update: was any debris left inside the patient? no. Did the blade become attached? no.
 
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Brand Name2.7 DEGREE STRAIGHT SAGITAL SAW
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9328753
MDR Text Key180869103
Report Number3005985723-2019-00811
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
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 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212186
Device Catalogue Number212186
Device Lot Number3500269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? No
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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: 11/15/2019 Patient Sequence Number: 1
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