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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 212480
Device Problem Application Program Problem: Parameter Calculation Error (1449)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Manufacturer Narrative
As part of 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
Our distal cut was showing 1. 5 deep with planar probe even though no red on screen was showing. We have had issues in last few weeks with cuts being too deep. We checked another cut made with straight attachment and it wasn¿t deep. Suspect that angled attachment may be going bad. No tourniquet was used. No surgical delay. Case type / application: tka.
 
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Brand Name2.7 DEGREE ANGLED 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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key14253970
MDR Text Key290467205
Report Number3005985723-2022-00051
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
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212480
Device Catalogue Number212480
Device Lot Number35030621 / 3518218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? No
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: 04/29/2022 Patient Sequence Number: 1
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