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Catalog Number 03.50.002
Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2016
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 27 april 2016. Lot 154331: (b)(4) items manufactured and released on 24 august 2015. Expiration date: 2020-07-20. No anomalies found related to the problem. To date, no similar event has been already reported on items of the same lot.
Event Description
During the phase of loading the pedicle screw onto the screwdriver, the scrubbed nurse was unable to accomplish the action. She tried to load the implant with two different screwdrivers with no success. Same operation was tried by the surgeon with no success. Another implant (same catalog number) was then opened with success of loading onto the screwdriver. This way was lost no more than 2 minutes to proceed to the next step of the surgery. The surgery was fully achieved with success.
Manufacturer Narrative
On 26 july 2016 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: two polyaxial pedicle screws lot 154331 were returned. One can be engaged normally to the pedicle screwdriver, the second can't. The pedicle screwdriver engages both the torx recess of the screw shaft, and the thread of the screw head (tulip) and fix them in co-axial position. With the defective screw, both the torx recess and the tulip thread are conform, but they cannot be aligned to each other by means of the pedicle screwdriver which therefore cannot be engaged to the tulip. The problem is related to a wrong assembling of the inlay, which is the intermediate component that ensures the mobile coupling of screw shaft and tulip. The tulip, in turns, is secured by a pin. In the normal screw, the inlay is free to move, allowing the poli-axiality. In the defective screw, the inlay is stuck in a position and moreover it can be seen that the pin is not properly inserted but it protrudes from the side. This defect prevents the screw shaft and tulip to be aligned by means of the pedicle screwdriver. Procedures and control methods are in place to guarantee the correct assembling of the pedicle screw. Moreover the second screw of the same lot is free of this defect. No similar event was ever reported. It can be assumed that this defect is a isolated case. Also it has to be noted that the defect doesn't affect the safety of the pedicle screw itself. It prevents the screw to be implanted with the dedicated instrument. The user always have multiple screws available in the or therefore he can open another screw to proceed with the surgery. On 27 july 2016 it was prepared a final report with the information submitted in this report and in the initial one. On 25 august 2016 the report was sent to the initial reporter and the case was closed.
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Brand NamePEDICLE SCREW 4.5 X 25 MM
Manufacturer (Section D)
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
91 6966060
MDR Report Key5619805
MDR Text Key44038446
Report Number3005180920-2016-00193
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
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 08/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2020
Device Catalogue Number03.50.002
Device Lot Number154331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2015
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: 04/29/2016 Patient Sequence Number: 1