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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 STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 111653
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
Event Type  malfunction  
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
Stryker rep reported that there was an incident regarding a checkpoint. Professor fehily performed 1x mako total hip procedures on the (b)(6) 2018. When removing the pelvic checkpoint from the patient it was retrieved incomplete with the remainder of the checkpoint pin potentially being left in the patient. No attempt was made to retrieve the remaining metal that was thought to be in the patient.
 
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Brand NameCHECKPOINT, 3.5 HEX IMPACTION STERILE
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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8205125
MDR Text Key131714814
Report Number3005985723-2018-00801
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGB
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,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number111653
Device Lot NumberTBC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? No
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: 12/28/2018 Patient Sequence Number: 1
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