MAUDE Adverse Event Report: SPINEART SA STRAIGHT ROD TITANIUM PERLA

Model Number	CPF-SR T2 40-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 20.Sep.2024, we received a complaint from the field, from austria, reporting that, after a perla surgery realized on (b)(6) 2022, the patient heard a crack then crackling noise in (b)(6) 2023.Radiological image shows the broken rod.Rod was explanted and replaced on (b)(6) 2023 (end of sade).The rod was scrapped on site.The reference and the batch number of the explanted rod are not available.Neither the pi nor the monitor could find the label.
Additional Manufacturer Narrative
When we received the complaint (b)(4) on 20.Sep.2024, the reference and the batch number of the explanted rod were not available.Neither the pi nor the monitor could find the label.Based on the invoices, we identified the reference and the batch number of the rods implanted: cpf-sr t2 40-s, 6-0651.The manufacturing folder has been reviewed.The analysis of the manufacturing documents and control quality documents confirmed that the raw materials and production processes were conforming to the specifications.Complained device belongs to a batch of (b)(4) units, manufactured in june 2021.This is the first complaint we receive for this batch.We received the postoperative pictures taken on (b)(6) 2023 and we clearly see that the rod is broken.Device component fracture is a side effect, specific to the implant, clinically well-known, it is reported in the ifu and cer.Based on the above information, we conclude that this issue is not linked to a device deficiency but linked to the patient condition (rheumatoid arthritis and degenerative disease) and the complexity of the construction.We decided to inform fda via (b)(4) because the device involved is us marketed.

• Brand Name: STRAIGHT ROD TITANIUM PERLA
• Common Device Name: STRAIGHT ROD TITANIUM PERLA
• Manufacturer (Section D): SPINEART SA; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 20320774
• Report Number: 3007728266-2024-00014
• Device Sequence Number: 7613440
• Product Code: NKG
• UDI-Device Identifier: 07640178976917
• UDI-Public: (01)07640178976917(17)280624(10)5-3848
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K153386
• 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: Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: Lay User/Patient
• Device Model Number: CPF-SR T2 40-S
• Device Catalogue Number: CPF-SR T2 40-S
• Device Lot Number: 6-0651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 76 YR
• Patient Sex: Female