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

Model Number MID-C 125

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 07/03/2021

Event Type  Injury  

Manufacturer Narrative

Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.User (surgeon and patient) information analysis: the screw was inserted out of the pedicle and the poly-axiality was completely locked as demonstrate at 2 weeks follow up x ray ,the lock of the poly -axaiality caused axial force on the implant, resulting its breakage.Corrective action: over the years, the company already implemented corrective action with the following: in (b)(6) 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.In (b)(6) 2020, the topic of practicing severe sports was added to the mid-c training presentation.Risk assessment: the current device breakage rate due to any reason is (b)(4) and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report ( 0.2%-15.5%) ( cer dms: (b)(4)).The risk of the broken rod has been assessed and found to be acceptable ((b)(4)).

Event Description

The surgeon reported follow up x-ray on (b)(6) 2021 demonstrate implant breakage.The patient is painful the surgeon plan to remove the implant.

• 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: 12457693
• MDR Text Key: 272882885
• Report Number: 3013461531-2021-00029
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/14/2021
• Device Model Number: MID-C 125
• Device Catalogue Number: AF 125
• Device Lot Number: AF 03-01-16
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/11/2021
• Date Device Manufactured: 03/14/2016
• 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