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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 25MM LONG - PEDICLE SCREW Ø5X45 FENESTRATED

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MEDACTA INTERNATIONAL SA MUST LT 25MM LONG - PEDICLE SCREW Ø5X45 FENESTRATED Back to Search Results
Model Number 03.57.025
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 11/11/2021
Event Type  Injury  
Manufacturer Narrative
Product code, k number and udi number are from must lt not fenestrated because must lt fenestrated is not registered in usa but the set screws are the same used in must lt not fenestrated. In this event, 2 set screws unscrewed. Four pedicle screws were revised. It is not known which of all the implants have been revised. Clinical evaluation performed by medical affairs director. In a long spinal stabilization surgery, two pedicle screws are implanted too deep and cannot be reached by the long rods. The set screws were implanted all the same but could not be properly tightened and therefore got loose. Subsequent surgery took away the loose screws but could not push the rod to reach the deep pedicle screws. The cause for the second surgery is not to be sought in a defective implant. Batch review performed on 06-december-2021. Lot 2024208: (b)(4) items manufactured and released on 29-sep-2021. Expiration date: 2026-06-29. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event. Other components potentially involved: must lt 03. 79. 215 must lt 25mm long - pedicle screw ø5x45 fenestrated lot. 2024202. Lot 2024202: (b)(4) items manufactured and released on 30-sep-2021. Expiration date: 2026-06-29. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event. Must lt 03. 79. 226 must lt 25mm long - pedicle screw ø6x50 fenestrated lot. 2123538. Lot 2123538: (b)(4) items manufactured and released on 06-sep-2021. Expiration date: 2026-08-18. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event. Must lt 03. 79. 226 must lt 25mm long - pedicle screw ø6x50 fenestrated lot. 2123539. Lot 2123539: (b)(4) items manufactured and released on 06-sep-2021. Expiration date: 2026-08-18. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event. Must lt 03. 79. 236 must lt 25mm long - pedicle screw ø7x50 fenestrated lot. 2123548. Lot 2123548: (b)(4) items manufactured and released on 29-sep-2021. Expiration date: 2026-07-12. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event Description
A long-construct must lt surgery without any final x-rays control has been completed. After the patient was repositioned to the side for the vertebral body replacement, an intraoperative ct scan was performed and it was discovered that two must lt set screws were unscrewed. The must lt instruments were unsterile, so, no repositioning was possible. Revision surgery was then performed removing the two setscrews plus four pedicle screw. Given that one pedicle screw was too deep was left without the set screw and was not removed. The rod was left and it was not fixed in some points.
 
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Brand NameMUST LT 25MM LONG - PEDICLE SCREW Ø5X45 FENESTRATED
Type of DevicePEDICLE 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 Key12948213
MDR Text Key281832169
Report Number3005180920-2021-00953
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07630971278394
UDI-Public07630971278394
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K203482
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,Followup,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number03.57.025
Device Catalogue Number03.79.225
Device Lot Number2024208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2021
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: 12/07/2021 Patient Sequence Number: 1
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