• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM SPINE POLY-AXIAL PEDICLE SCREW

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM SPINE POLY-AXIAL PEDICLE SCREW Back to Search Results
Model Number 03.52.322
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2022
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 20 july 2022: lot 2123283: (b)(4) items manufactured and released on 12-july-2021. Expiration date: 2026-06-27. No anomalies found related to the problem. To date, 33 items of the same lot have been sold without any similar reported event during the period of review.
 
Event Description
The top right side screw (l4) was displaced laterally about a week post-primary. The surgeon revised 2 screws and the rod (6x35 screws and 35mm rod). The surgeon suspects poor bone quality as the reason. The screw was initially well placed using the myspine drill guides.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
Type of DeviceSPINE POLY-AXIAL 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 Key15174142
MDR Text Key297342019
Report Number3005180920-2022-00605
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07630030857577
UDI-Public07630030857577
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141988
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 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number03.52.322
Device Catalogue Number03.52.322
Device Lot Number2123283
Was Device Available for Evaluation? No
Date Manufacturer Received07/17/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/12/2021
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: 08/05/2022 Patient Sequence Number: 1
-
-