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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO_ROBOT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. UNKNOWN_MAKO_ROBOT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNK_OFL
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 07/30/2020
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. Device not returned.
 
Event Description
It was reported, "on (b)(6) 2020, patient (b)(6) (years old) had a surgical operation on her knee at the best private hospital of the country, applying your technology (robotics). After about 60 physiotherapist sessions, doctor's assistance and the lapse of a 10- month period, still have problems, as, the knee continues to swell after a walk of each day. A permanent difficulty exists in standing up and walk, when either getting-up from bed or from a chair after sitting for over 15 minutes. After the every day exercise in walking over a mile, there is tightening and fatigue on the knee. Straight alignment of the knee was never restored. Almost every day the patient takes painkillers to make it through the day. This disappointment led us to pay a visit to another orthopedic dr whose comments are: the most common surgery applied on patients at the age of 70-years-old + is a full repair of the knee and not half as it was done in our case, and something might be wrong or not a perfect fit. Recently there is pain on both sides of the leg (tibia and calf) every day after standing or walking. ".
 
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Brand NameUNKNOWN_MAKO_ROBOT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12032360
MDR Text Key261252705
Report Number3005985723-2021-00108
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
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
Date Manufacturer Received05/17/2022
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: 06/21/2021 Patient Sequence Number: 1
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