MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC CROSS-CONNECTOR 19-29MM ADJUSTABLE; SPINE CROSS CONNECTOR

Model Number	03.56.503
Medical Device Problem Codes	Material Deformation (2976); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 january 2023.Lot: 2126491: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-nov-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the event, batch review performed on 16 january 2023: pedicle screw 03.52.337 enh.Poly-axial pedicle screw - cannulated 7x40mm (k141988) lot: 2127340 lot: 2127340: (b)(4) items manufactured and released on 10-jan-2022.Expiration date: 2026-dec-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Primary surgery performed 6 months ago (july 2022), l4-l5-s1 tlif.Six months later, l4-l5 presented bony fusion, however, l5-s1 resulted in pseudoarthrosis with s1 screw loosening.The cross-connector was located at l4-l5.At the revision surgery, the cross-connector was not stable already before removing the set screws.L4 and l5 pedicle screws were ok without any signs of loosening and l4-l5 was completely fused, but the cross-connector at l4-l5 showed loosening; while in l5-s1 was non-union and s1 screws were loose.
Additional Manufacturer Narrative
Visual inspection performed on 20 february 2023 by medacta spine r&d project manager: the implant appears to be torsionally twisted.A new implant of the same reference has been taken off the shelf and has been twisted on purpose, using the countertorque.It was not possible to replicate the deformation of the implant object of the complaint, therefore a failure during implant insertion and final tightening has to be excluded.A certain root cause cannot be identified with the available information.

• Brand Name: PEDICLE SCREW MUST MC CROSS-CONNECTOR 19-29MM ADJUSTABLE
• Common Device Name: SPINE CROSS CONNECTOR
• 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 Key: 16332042
• Report Number: 3005180920-2023-00055
• Device Sequence Number: 12480956
• Product Code: NKB
• UDI-Device Identifier: 07630040728799
• UDI-Public: 07630040728799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Model Number: 03.56.503
• Device Catalogue Number: 03.56.503
• Device Lot Number: 2126491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian