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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IMPACTOR HANDLE; KNEE ARTHOPLASTY IMPLANTATION SYSTEM
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CONFORMIS, INC. ITOTAL IMPACTOR HANDLE; KNEE ARTHOPLASTY IMPLANTATION SYSTEM Back to Search Results
Model Number ED-07827
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that the strike plate broke off the impactor handle during surgery.The surgeon utilized the handle to complete the surgery by hitting the small section of strike plate left exposed.There were no adverse consequences to the patient.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the strike plate broke off the impactor handle during surgery.The surgeon utilized the handle to complete the surgery by hitting the small section of strike plate left exposed.There were no adverse consequences to the patient.
 
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Brand Name
ITOTAL IMPACTOR HANDLE
Type of Device
KNEE ARTHOPLASTY IMPLANTATION SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer (Section G)
CONFORMIS, INC.
600 research drive
wilmington MA 01887
Manufacturer Contact
emmanuel nyakako
600 technology park drive
billerica, MA 01821
7813459164
MDR Report Key11091671
MDR Text Key225117466
Report Number3004153240-2020-00240
Device Sequence Number1
Product Code OOG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170226
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberED-07827
Device Lot NumberE202701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2020
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 Sequence Number1
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