MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MONOAXIAL SCREW 6X45MM; SPINE PEDICLE SCREW

Catalog Number 03.50.244

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19.July.2019; lot 1621032: 75 items manufactured and released on 20-oct-2017.Expiration date: 2022-10-04.No anomalies found related to the problem.To date, 28 items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta spine r&d director: the surgeon didn't use any reduction instrument a tried to get the set screw started freehand despite of the fact that the rod wasn't fully seated inside the acuity of the tulip.This could potential have caused the high stress on a small area of the thread and as a consequence the failure.In any case we have to analyses the physical part as soon as available.

Event Description

During the revision spine surgery, and while the surgeon was tightening the set screw after adjusting the rod, the internal threads on the tulip broke.Fragments fell into the patient and were retrieved and the surgeon completed the case by implanting a poly-axial reduction screw.There was a 15-minute delay in the case and the surgery was completed successfully.

Manufacturer Narrative

Visual inspection performed by r&d project manager the monoaxial screw, ref (b)(4) lot.1621032, analized has some of scratches on the outer surfaces of the head and one and an half setscrew thread missing.The scratches are probably caused by the manoeuver to insert the rod into the tulip head or for the removal.The setscrew missing thread was probably due to the high stress on a small area of the thread due to the fact that the surgeon tried to perform the reduction freehand and without the helping of any reduction instrument.

• Brand Name: PEDICLE SCREW MONOAXIAL SCREW 6X45MM
• Type of Device: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8840209
• MDR Text Key: 215121128
• Report Number: 3005180920-2019-00642
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030835087
• UDI-Public: 07630030835087
• Combination Product (y/n): N
• PMA/PMN Number: K132878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 03.50.244
• Device Lot Number: 1621032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other