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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CABLE,TRANSMISSION, J5 INSIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. CABLE,TRANSMISSION, J5 INSIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 203251
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2020
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
Case description: rob690 - mps reported arm shaking during tibia and posterior femur cut. Case type : tha. Update: surgical delay "less than 15 minute delay. ".
 
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Brand NameCABLE,TRANSMISSION, J5 INSIDE
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 Key10474832
MDR Text Key205100079
Report Number3005985723-2020-00289
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number203251
Device Lot NumberUNKNOWN
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 Received10/23/2020
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: 08/31/2020 Patient Sequence Number: 1
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