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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 210080
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 02/04/2020
Event Type  malfunction  
Manufacturer Narrative
Reported issue - surgeon brought to attention that the leg holder had chipped and had an exposed sharp edge. Product inspection - visual inspection confirmed leg holder is chipped. Product history review ¿ a review of the product history records indicates that 20 devices were manufactured under catalog #210080 lot no 201843101633, and all were accepted into final stock on 02/03/2020. There were no non-conformities identified during inspection. Complaint history review ¿ a review of complaints related to p/n (b)(4), lot 201843101633 shows no additional complaint(s) related to the failure in this investigation. Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event. Conclusion ¿ the event was confirmed. Per (b)(4), preventive maintenance is where an action occurs that identifies device deterioration which may compromise function. Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event. No additional investigation or specific actions are required.
 
Event Description
Surgeon brought to attention that the leg holder had chipped and had an exposed sharp edge. Case type: tka.
 
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Brand NameBOOT ASSEMBLY
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9765805
MDR Text Key181574922
Report Number3005985723-2020-00118
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486031879
UDI-Public00848486031879
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 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number210080
Device Catalogue Number210080
Device Lot Number201843101633
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 Received02/27/2020
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: 02/27/2020 Patient Sequence Number: 1
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