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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number UNK_OFL
Device Problem Device Slipped (1584)
Patient Problem Damage to Ligament(s) (1952)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative
As part of 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
After trialing the implants, the doctor noticed that the mcl was cut. Smiley and thin bent retractors were used during the case. The doctor claims it's the side of the sawblade that cut it. Surgical delay
=
15 minutes. Case type: tka. Update per response: "we assume the straight sawblade, but we can¿t know for sure. The doctor believes that it is more of an issue with retraction with the smiley retractor. The mcl had to be repaired. " right side.
 
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Brand NameUNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
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 Key9831962
MDR Text Key183357076
Report Number3005985723-2020-00154
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 Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_OFL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? No
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: 03/13/2020 Patient Sequence Number: 1
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