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

Model Number MID-C 125

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Implant Pain (4561)

Event Date 09/20/2021

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 trial tool, size gauge, and extender angle measurement tool were not used correctly.The company contacted the surgeon and retrained him on the surgical technique.The surgery was performed on (b)(6), the x-ray demonstrates that the apifix distal screw has begun to pull out of the pedicle.The patient reported that the event occurred while exercising in pt class.Movements such as sit-ups and alike may lead to screw pull-out.The risk assessment: the current device screw pulls out rate due to any reason is 1.39% 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 ((b)(4)).The risk of the screw pull out has been assessed and found to be acceptable ((b)(4)).

Event Description

Patient participate in clinical study (b)(6) ( fda post-approval study per protocol (b)(4)).The surgeon report that the distal screw has begun to pull out of the pedicle.

• 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: 12675344
• MDR Text Key: 278138936
• Report Number: 3013461531-2021-00034
• 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,study,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

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 Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-07-036-20
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2021
• Date Device Manufactured: 08/01/2020
• 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