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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. SQUARE SCREWDRIVER STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. SQUARE SCREWDRIVER STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 111160
Device Problem Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
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
Silver end of square driver came loose from the blue handle while taking apart arrays/array clamps. Case type: pka (anspach). Surgical delay: > 30 minutes.
 
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Brand NameSQUARE SCREWDRIVER
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
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 Key9378968
MDR Text Key189676180
Report Number3005985723-2019-00856
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number111160
Device Catalogue Number111160
Device Lot Number06110518
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
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: 11/26/2019 Patient Sequence Number: 1
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