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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNIBOTICS KNEE SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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OMNILIFE SCIENCE, INC. OMNIBOTICS KNEE SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 4145-5003
Device Problem Device Slipped (1584)
Patient Problem Tissue Damage (2104)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.
 
Event Description
The complaint involved a patient who underwent a primary knee surgery on (b)(6) 2018. During the case, a 4 to 6mm femoral notch was cut into the bone unexpectedly. Patient bone was soft, and the cutting block and pins shifted during use.
 
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Brand NameOMNIBOTICS KNEE SYSTEM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
Manufacturer (Section G)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
Manufacturer Contact
george cipolletti
480 paramount drive
raynham, MA 02767
MDR Report Key8121919
MDR Text Key129021684
Report Number1226188-2018-00179
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K090953
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4145-5003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2018 Patient Sequence Number: 1
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