MAUDE Adverse Event Report: APIFIX LTD MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Inaccurate Information (4051)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Production process data analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.User (surgeon) information analysis: the follow up x-ray from (b)(6) 2021 demonstrates extender misalignment with an angle over 45 degrees.In addition, the distance from the extender's head to the pedicle screw is way over 4-5 mm apifix recommend.Corrective action: the company introduced the use of the extender component (eco 18) in (b)(6) 2017 and experienced a learning curve with its use.Extender misalignment results from not properly aligning the extender and the main rod, from selecting improper screw size to anchor the extender or from fault in the off the shelf tool used to lock the extender screws.The event may be associated with curve progression, implant migration and prominence.The company took several actions to mitigate extender misalignment: in (b)(6) 2018, a letter instructing surgeons how to properly align the extender was issued.Eco 48, a pre-bent extender was introduced to ease extender alignment.Eco 63, an extender-main rod angle measurement tool was added to the surgical tool.The current case was one of the first cases performed with an extender, prior to any of the company's mitigation for use of the extender.Risk assessment: he root cause for the prominence of the extender is its misalignment and hence it is classified accordingly.At the time of this report ((b)(6) 2021), the company's incident rate of extender misalignment is 2.4%.The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable (dms# (b)(4).Hazard id (b)(6)).

Event Description

The surgeon reported that the patient not satisfaction since the conjunction between the rod and the extension is protruding under the skin.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12457700
• MDR Text Key: 272859889
• Report Number: 3013461531-2021-00030
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2021
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-01-16
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Date Device Manufactured: 11/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention