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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 112230
Device Problems Material Integrity Problem (2978); Premature Separation (4045)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
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
The vizadiscs pop off the array when impacting the cup. This has occurred previously and were placed back on to finish cases. Dr cornelius asked that i have the array replaced now that is has reoccurred. Case type: tha.
 
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Brand NamePELVIC ARRAY ASSY
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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8858167
MDR Text Key155697206
Report Number3005985723-2019-00548
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121064
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number112230
Device Lot Number19050811
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 Received10/31/2019
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: 08/02/2019 Patient Sequence Number: 1
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