MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X40MM

Catalog Number	03.52.337
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 september 2019.Lot 1721529: (b)(4) items manufactured and released on 25-jan-2018.Expiration date: 2023-01-11.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.Visual inspection performed by r&d project manager.The cannulated enhanced ø7 pedicle screw inserted in l4 got loosened and was replaced by a solid one (ø is unknown).A potential root cause could be the poor bone quality (as indicated in the complaint) and the not sufficient grip of the screw thread at the cortical level.The thread of the inspected screw does not present any defects, scratches or damaged parts.The design of the upper part of the screw thread (close to screw head) is the same for all medacta's screw types (solid, cannulated, enhanced, fenestred, etc.) and the distance between the tulip lower surface and the beginning of the thread is fixed at 5mm when the screw is a straight position.
Event or Problem Description
Pps surgery performed at l4/5.The patient bone quality was poor.The enh.Poly-axial pedicle screw cannulated 7x40mm was inserted at the left of l4, but it loosened.One possible reason was the pedicle screw thread was not fully designed, so the thread could not be fixed at the cortical bone completely and it was not able to obtain the fixing force.The revision surgery performed immediately by open surgery.Pedicle screw was replaced with the backup solid screw.Due to this event, the surgery was prolonged about 30 minutes.Total surgery time was 180min.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X40MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9174355
• Report Number: 3005180920-2019-00854
• Device Sequence Number: 3146763
• Product Code: NKB
• UDI-Device Identifier: 07630030857751
• UDI-Public: 07630030857751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: 03.52.337
• Device Lot Number: 1721529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/10/2019
• 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: Required Intervention