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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW

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MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW Back to Search Results
Catalog Number 03.52.323
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2018
Event Type  Malfunction  
Manufacturer Narrative

On 20 july it was added the lot of the instrument is unknown. On 26 july 2018 the r&d project manager made the following analysis: difficulty to engage the set screw into the pedicle screw head (tulip), after rod reduction. The issue is confirmed by attempting to place the set screw without the rod. The issue can be caused by a defect of the thread of the tulip. However the same thread is used to couple the screw to the pedicle screwdriver at the first steps of the surgery, therefore the thread cannot have been defective from the beginning. The defect/deformation could have occurred during the reduction manoeuvre/first attempt to engage the set screw. Or the defect can be on the set screw. Detailed analysis will be performed with the devices as soon as available. On 27 july 2018 the medical affairs director made the following analysis: during a percutaneous lumbar posterior stabilization surgery, difficulty was encountered placing the set screw on one of the l5 pedicle screws, which was therefore removed and exchanged. No further problem was encountered. We do not think that the cause for this inconvenience can be of clinical origin. No clinical consequence should be expected apart from the surgery being lengthened by approximately 30 minutes, according to the report. Batch review performed on 30 july 2018: lot 1721554: (b)(4) items manufactured and released on 08 june 2018. Expiration date: 2023-04-05. No anomalies found related to the issue. To date, (b)(4) items of the same lot have been already sold without any similar reported event. The set screw lot has been checked too: (b)(4) items released, with no anomalies related to the issue.

 
Event Description

When the surgeon was trying to insert the set screw into the pedicle screw head which was already implanted at l5, it was not able to insert, even though the surgeon used the reducer. Then he tried to insert without the rod, but it was not able. Since it was doubtful whether the issue was with pedicle screw head or percutaneous tower, the pedicle screw was replaced with a more large size. The surgery was performed by pps and finished successfully. Due to this event the surgery was prolonged about 30 minutes.

 
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Brand NameMUST PEDICLE SCREW
Type of DevicePEDICLE 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
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key7734728
MDR Text Key115652819
Report Number3005180920-2018-00597
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK141988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number03.52.323
Device LOT Number1721554
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/08/2018
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/31/2018 Patient Sequence Number: 1
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