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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 8X50MM SPINE PEDICLE SCREW

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MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 8X50MM SPINE PEDICLE SCREW Back to Search Results
Model Number 03.50.056
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Inadequate Osseointegration (2646)
Event Date 02/16/2022
Event Type  Injury  
Event Description
Revision surgery due to screw loosening. 2 screws were exchanged with 10x50 mm. Primary surgery date unknown. The patient's bone was slightly osteoporotic according to the surgeon.
 
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Brand NamePEDICLE SCREW PEDICLE SCREW 8X50MM
Type of DeviceSPINE PEDICLE SCREW
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 Key13803783
MDR Text Key287430179
Report Number3005180920-2022-00178
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07630030834431
UDI-Public07630030834431
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K132878
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 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number03.50.056
Device Catalogue Number03.50.056
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2022
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 Treatment Data
Date Received: 03/18/2022 Patient Sequence Number: 1
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