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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO BONE PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. UNKNOWN MAKO BONE PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNK_OFL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 03/22/2020
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 through the filing of a lawsuit that allegedly on or about (b)(6) 2020, a mako total knee with triathlon was implanted into the patient's right knee using product/robotic assistance, pinning the product to the patient's femur. It is further alleged that on or about (b)(6) 2020, the patient's femur broke as a direct result of the product and implantation, and he underwent subsequent surgery as a result of his injuries.
 
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Brand NameUNKNOWN MAKO BONE PIN
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key13925262
MDR Text Key288021231
Report Number3005985723-2022-00035
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 Other
Reporter Occupation
Type of Report Initial
Report Date 03/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2022 Patient Sequence Number: 1
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