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

Model Number MID-C 125

Device Problem Off-Label Use (1494)

Patient Problem Physical Asymmetry (4573)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

First investigation: 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 patient is a (b)(6) year old male, risser 0 with a pre-op primary curve cobb of 49° and flexible.Immediate post-op x-rays, demonstrate that the implant was well positioned and that the curve was reduced to 35°.Later x-ray demonstrates that the extender-rod angle on lateral view demonstrates that the polyaxial joint is locked or almost locked.Five months post-surgery the main curve progressed to 52°, the system lower screw pulled out and the spine was imbalanced.Based on the available data, a possible reason for the screw pullout (failure) is the rapid progression of the patient's scoliosis from 35° to 52° in parallel to the polyaxial joint of the extender-rod leading to improper alignment of the extender with the mid-c rod, inducing high pullout forces on the distal pedicle screw.The company chief medical officer advised the surgeon to remove the system and fuse the spine, however the patient's family requested to have a new mid-c system implanted.Revision surgery is planned to (b)(6) 2022.

Event Description

The surgeon contacted apifix to consult regarding to this patient due to evidence of distal screw pull out.The patient was treated outside the indications for use (non-ais).

Manufacturer Narrative

Patient was revised to a new mid-c system on (b)(6) 2022.No report of patient harm or complications was received.

• 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: 13478028
• MDR Text Key: 285355549
• Report Number: 3013461531-2022-00002
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-01-069-21
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Date Device Manufactured: 01/28/2021
• 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