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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 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. MAKO 2.7 DEGREE ANGLED SAGITTAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 212480
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
Mako robot was used for left knee replacement. 2. 7 degree angled sagittal saw attachment would not lock onto mako arm. Device released to on-site company representative (b)(6). Company sending a replacement. Fda safety report id # (b)(4).
 
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Brand NameMAKO 2.7 DEGREE ANGLED SAGITTAL SAW
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
MDR Report Key13976773
MDR Text Key288496248
Report NumberMW5108695
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 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212480
Device Catalogue Number212480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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