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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE PRODUCT
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MEDACTA INTERNATIONAL SA SPINE PRODUCT Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 11/05/2020
Event Type  Injury  
Event Description
The surgeon notified a competitor sales representative that a patient implanted with medacta hardware needed to undergo a revision surgery.The cause of the revision surgery is unknown at this time.The competitor sales representative contacted medacta in order to obtain removal drivers to use during the revision surgery.There is no additional information at this time.A revision surgery has not been scheduled yet.More to follow once information becomes available.
 
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Brand Name
SPINE PRODUCT
Type of Device
SPINE PRODUCT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ   6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key10935190
MDR Text Key219179121
Report Number3005180920-2020-00867
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
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 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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