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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW 8X40MM

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MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW 8X40MM Back to Search Results
Catalog Number 03.50.054
Device Problem Device Issue (2379)
Patient Problems Arthritis (1723); Pain (1994)
Event Date 10/23/2017
Event Type  Injury  
Manufacturer Narrative
Batch reviews performed on 20 november 2017. Lot 160534: (b)(4) items manufactured and released on 07 march 2016. Expiration date: 2021-02-15. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Must pedicle screw 7x50mm, code 03. 50. 032, lot. 160531 (k121115). (b)(4) items manufactured and released on 11 march 2016. Expiration date: 2021-02-01. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Must pedicle screw 7x45mm, code 03. 50. 031, lot. 165548 (k121115) (b)(4) items manufactured and released on 28 november 2016. Expiration date: 2021-11-06. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Must pedicle screw 7x50mm, code 03. 50. 032, lot. 161898 (k121115) (b)(4) items manufactured and released on 30 may 2016. Expiration date: 2021-04-06. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Must pedicle screw 8x40mm, code 03. 50. 054, lot. 153403 (k132878) (b)(4) items manufactured and released on 06 july 2017. Expiration date: 2020-06-03. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event Description
The patient had a primary fusion of l3-s1. The patient came in complaining of right leg pain and lower back pain. The patient presented with pseudo arthritis. The surgeon determined that the screws backed out. The surgeon revised all medacta screws and rods. The surgery was completed successfully.
 
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Brand NameMUST PEDICLE SCREW 8X40MM
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, 6874
SZ   6874
MDR Report Key7052116
MDR Text Key92723715
Report Number3005180920-2017-00688
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07630030834417
UDI-Public07630030834417
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2021
Device Catalogue Number03.50.054
Device Lot Number160534
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2016
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: 11/22/2017 Patient Sequence Number: 1
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