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

Model Number MID-C 125

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

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 had a diagnosis of early-onset scoliosis (eos) and was implanted at age (b)(6) years with the mid-c 125 with 40 mm extension as part of the company's clinical study.Based on the patient's x-ray the broken rod occurs at the main rod-extender junction the patient's kyphosis significantly increased to 70° at the last follow-up.Also, the x-rays show that the angle between the main rod and the extender was 36 degrees, indicating this polyaxial joint is completely locked (15 degrees extender pre-bending plus 20 degrees joint polyaxiality).Increase in kyphosis angle resulted forces acting on the locked joint, resulting in the breakage.Risk assessment: the main aim of the surgery in the eos population is to correct the spinal deformity, allowing the spine and lungs to grow while controlling the deformity until the child is close to skeletal maturity so he or she can have a definitive spinal fusion.The standard of care in the field of growth sparing devices used for the eos population, distraction-based, and guided growth, require periodical surgical interventions to lengthen the implanted rod.Per clinical evaluation report rev t, reported complications in this population are relatively high ( 20-80%) due to the nature and the complexity of the disease.In eos patients with increased kyphosis, the rod may be under high compressive loading, and intermittent distractions may lead to cyclical fatigue of growth implants, which therefore increases the risk of rod fracture and hence present more challenges concerning complications, including implant-related complications.Chen et al [1] demonstrated in a study comparing treatment in eos patients with and without hyperkyphosis that the most common implant-related and alignment-related complication in the eos hyperkyphotic population was rod fracture.[1]chen z, qiu y, zhu z, li s.How does hyperkyphotic early-onset scoliosis respond to growing rod treatment 2016;00:1-6.

Event Description

On (b)(6) 2021, the study cra reported by e-mail that the device broke.Dr.(b)(6), the patient's surgeon updated that patient heard and felt a crack on her back a month ago, the x-ray showed a breakage of the mid-c.

• 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: 11326696
• MDR Text Key: 233159409
• Report Number: 3013461531-2021-00003
• 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,study,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2021

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: Health Professional
• Device Expiration Date: 11/21/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF-11-04-17
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/15/2021
• Date Device Manufactured: 11/21/2017
• 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