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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 Slipped (1584); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
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
During bone prep the doctor said that the screen was showing him cutting more medially than he actually was for the distal, posterior chamfer and posterior cuts. We ruled out any bumped bone arrays, checkpoints and base array/registration errors. No surgical delay. Case type / application: tka.
 
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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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12321028
MDR Text Key266678646
Report Number3005985723-2021-00140
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212186
Device Catalogue Number212186
Device Lot Number35130220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2020
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: 08/13/2021 Patient Sequence Number: 1
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