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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 213527
Device Problem Insufficient Information (3190)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/27/2020
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
On (b)(6) 2020, the patient underwent tka (left) for knee joint. Postoperative fracture occurred from the position of the pin insertion for femoral array installation. So, the patient under went revision on (b)(6) 2020.
 
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Brand NameBONE PIN, 3.2MM X 140MM, STERILE 2 PACK
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
joanne mahony
ida industrial estate
carrigtwohill, FL NA
EI   NA
9546280700
MDR Report Key10740218
MDR Text Key213198391
Report Number3005985723-2020-00321
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number213527
Device Catalogue Number213527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
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: 10/27/2020 Patient Sequence Number: 1
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