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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number EMAX2PLUS
Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010); Complete Loss of Power (4015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
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
Burr stopped working during tibia prep.Had to complete the case with manual instrument prep.I am requesting a new anspach motor be sent as soon as possible to replace a defective motor.Could you also send two new hd long attachments as well.Surgical delay 20 minutes.Case type: pka.
 
Manufacturer Narrative
Anspach emax 2 plus burr motor stopped working.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was confirmed.Device history review: not performed as the anspach emax 2 plus burr motor is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding anspach emax 2 plus burr motor stopped workingt failure of p/n: emax2plus, s/n: (b)(6).There have been no other similar events for the referenced serial number.Conclusions: the anspach emax 2 plus burr motor is an oem device.Upon receipt, the anspach emax 2 plus burr motor was bench evaluated by (b)(6) (engineer, r&d robotics) and the reported event was confirmed.
 
Event Description
Burr stopped working during tibia prep.Had to complete the case with manual instrument prep.I am requesting a new anspach motor be sent as soon as possible to replace a defective motor.Could you also send two new hd long attachments as well.Surgical delay 20 minutes.Case type: pka.
 
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Brand Name
ANSPACH® EMAX2 PLUS MOTOR
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9359784
MDR Text Key176239953
Report Number3005985723-2019-00815
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K080802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEMAX2PLUS
Device Lot NumberK34311675514
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/28/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received11/14/2019
Supplement Dates FDA Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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