MAUDE Adverse Event Report: CC PREFERRED ANGLED SCREW / ML PREFERRED ANGLED SCREW

Model Number CPF-CS 04 18-S / CPF-MS 04 18-S

Device Problem Loss of Osseointegration (2408)

Patient Problem Implant Pain (4561)

Event Date 07/13/2021

Event Type  Injury  

Event Description

On 30.Jan.2024, we received a complaint from the field (b)(4) reporting a screw loosening on c2 and a revision surgery.The initial surgery was realized on (b)(6) 2020.During a 12-month visit on (b)(6) 2021, screw loosening on c2 was detected on the ct scan.The intensity degree of the event was classified as moderate (disrupts usual daily activity), and a medication action was taken (who 3).The patient was readmitted for revision surgery on (b)(6) 2022: removal of c2 screws and additional screws in c1 and c3.Medical history: the patient had a previous spinal surgery, realized on (b)(6) 2020, a ventral fusion vertebral bodies c4-c7 with cages and plate (acis).The event is resolved.

Manufacturer Narrative

The devices implanted on c2 during the initial surgery were cpf-cs 04 18-s, batch number 3-7678 and cpf-ms 04 18-s, batch number 4-0573.After we received the complaint, the manufacturing folders have been reviewed.There is no non-conformity detected during the manufacturing steps.Raw material and dimensional controls are conforming to the specifications.Plus, we received surgery pictures: preoperative, immediate postoperative, 6-months postoperative and 12-months postoperative pictures.Screw loosening (loss of fixation) is part of the side effect specific to the implant, listed in the ifu.Since the launch of the product, 13617 screws have been implanted (preferred angle screws) and this is the third time we receive a complaint reporting this kind of issue, which represents 0,02% of issue.The rate is very low.We decided to report the case to the bfarm (german competent authority).

• Brand Name: CC PREFERRED ANGLED SCREW / ML PREFERRED ANGLED SCREW
• Type of Device: CC PREFERRED ANGLED SCREW / ML PREFERRED ANGLED SCREW
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 18748172
• MDR Text Key: 335935435
• Report Number: 3007728266-2024-00002
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CPF-CS 04 18-S / CPF-MS 04 18-S
• Device Catalogue Number: CPF-CS 04 18-S / CPF-MS 04 18-
• Device Lot Number: 3-7678 / 4-0573
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male