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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 111653
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/22/2022
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
As reported: "checkpoint was left in greater troch and removed post op. Surgical delay > 30 minutes. Case type / application: tha" spoke to mps. After surgery was complete and the patient was out of the o. R. , post-op x-ray showed the checkpoint left in the patient. Patient was brought back into the o. R. , put back under anesthesia, and the checkpoint was removed. There was no intra-operative delay, mps was trying to report that the removal took > 30 minutes. Mps may be able to provide some additional patient information.
 
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Brand NameCHECKPOINT, 3.5 HEX IMPACTION STERILE
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
perla zima
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key14135862
MDR Text Key289442902
Report Number3005985723-2022-00047
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number111653
Device Catalogue Number111653
Device Lot NumberW75839-1
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2022
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: 04/18/2022 Patient Sequence Number: 1
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