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

Model Number MID-C 105

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/02/2022

Event Type  Injury  

Event Description

The surgeon contacted apifix maayan yeheskeli international marketing manager apifix ltd regarding to this patient to inform that a revision surgery was done on (b)(6) 2022 due to curve progression.

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 initial surgery and the follow up x-ray demonstrate on curve progression, the curve progression was due to extender misalignment which was indicated on the post initial x-ray , the angle between the extender and the mid-c rod should be by design between 5-15° ,the x-ray demonstrate that the angle was less than 5°, also the extender that was choose is lenke 5 instead of lenke 1.

• Brand Name: MIID-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: 13692200
• MDR Text Key: 286843694
• Report Number: 3013461531-2022-00006
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial
• Report Date: 03/06/2022

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 Model Number: MID-C 105
• Device Catalogue Number: AF 105
• Device Lot Number: AF-10-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 03/08/2022
• Date Device Manufactured: 10/27/2019
• 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