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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO 2.7 DEGREE ANGLED SAGITTAL SAW ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. MAKO 2.7 DEGREE ANGLED SAGITTAL SAW ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 212480
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 04/05/2022
Event Type  Injury  
Event Description
Mako 2. 7 degree angled sagittal saw would not lock onto the mako robotic arm. Company representative (b)(6) present. Fda safety report id # (b)(4).
 
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Brand NameMAKO 2.7 DEGREE ANGLED SAGITTAL SAW ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
MDR Report Key14052567
MDR Text Key289004700
Report NumberMW5108838
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212480
Device Catalogue Number212480
Device Lot Number35080921
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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