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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA POLY-AXIAL PEDICLE SCREW - CANNULATED; SPINE CANNULATED PEDICLE SCREW
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MEDACTA INTERNATIONAL SA POLY-AXIAL PEDICLE SCREW - CANNULATED; SPINE CANNULATED PEDICLE SCREW Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 11/21/2023
Event Type  Injury  
Event Description
About 20 days after the primary surgery, the patient came in reporting pain.Neuromonitoring did not detect any issue and no issue was detected during the revision.The surgeon removed the right side l5 pedicle screw and did not replace it.The surgery was completed successfully.
 
Manufacturer Narrative
No analysis was possible for the limited information available.No device nor device lot or x-rays became available.
 
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Brand Name
POLY-AXIAL PEDICLE SCREW - CANNULATED
Type of Device
SPINE CANNULATED PEDICLE SCREW
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ   6874
Manufacturer Contact
marco giannessi
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key18354957
MDR Text Key330875965
Report Number3005180920-2023-00957
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
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 Received11/28/2023
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;
Patient SexFemale
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