MAUDE Adverse Event Report: APIFIX LTD MID-C 105; POSTERIOR RATCHETING ROD SYSTEM,

Model Number MID-C 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Surgeon information and x-ray analysis: after revision surgery ( mdr# 3013461531-2021-00014) the patient displayed significant torso imbalance.The patient was referred to schroth exercises in an attempt to resolve the imbalance.Risk assessment: the risk of spine imbalance is a known risk.The current spine imbalance complaint rate is 0.51% and has been assessed and found to be acceptable per the company cer.(dms-727 rev t) the event of spine imbalance is addressed in the ifu as potential risks associated with the mid-c system 1.Curve progression above or below the implant 2.Lordosis/kyphosis changes.

Event Description

The patient contacted the surgeon for a virtual consult on additional treatment options to replace the apifix system.

Manufacturer Narrative

Investigation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Surgeon information and x-ray analysis: after revision surgery ( mdr# 3013461531-2021-00014) the patient displayed significant torso imbalance.The patient was referred to schroth exercises in an attempt to resolve the imbalance.Risk assessment: the risk of spine imbalance is a known risk.The current spine imbalance complaint rate is (b)(4) and has been assessed and found to be acceptable per the company cer.(dms-727 rev t) the event of spine imbalance is addressed in the ifu as potential risks associated with the mid-c system 1.Curve progression above or below the implant 2.Lordosis/kyphosis changes.

Event Description

The patient contacted the surgeon for a virtual consult on additional treatment options to replace the apifix system.

• Brand Name: MID-C 105
• 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: 12983521
• MDR Text Key: 285643069
• Report Number: 3013461531-2021-00045
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2021

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 Expiration Date: 11/22/2022
• Device Model Number: MID-C 105
• Device Catalogue Number: AF 105
• Device Lot Number: AF 11-05-17
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/13/2021
• Date Device Manufactured: 11/22/2017
• 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