MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION CANNULATED PEDICLE SCREW 7X45

Catalog Number	03.52.731
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 1820919: (b)(4) items manufactured and released on 03-aug-2018.Expiration date: 2023-06-10.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, but two items of this same lot have been involved in the current case.
Event or Problem Description
Plif surgery performed at l4-l5-s.The surgeon tried to insert the set screw into the reduction cannulated pedicle screw tulip at left side of l4, but the he was not able to insert it completely.The set screw spinned around the rod.It was doubtful that the thread of pedicle screw tulip deformed, so the surgeon replaced the reduction pedicle screw with new standard pedicle screw.After that the surgeon adjusted the rod bending again and tried to insert the set screw into the reduction cannulated pedicle screw tulip at left side of s1, the thread of pedicle screw tulip seemed to be deformed with the cross-threading.After many attempts with locking tower, finally he was not able to insert the set screw, so he replaced pedicle screw with the new one.Due to this event the surgery was prolonged about 30 minutes.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the thread of the pedicle screws analized is damaged.The damaging seems to be compatible with a cross threading.The root cause of the cross threading is not clearly identified.

• Brand Name: PEDICLE SCREW REDUCTION CANNULATED PEDICLE SCREW 7X45
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8456539
• Report Number: 3005180920-2019-00194
• Device Sequence Number: 19239592
• Product Code: NKB
• UDI-Device Identifier: 07630030847226
• UDI-Public: 07630030847226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2023
• Device Catalogue Number: 03.52.731
• Device Lot Number: 1820919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR