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

Model Number MID-C 125

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.The x-ray demonstrates that the patient was out of indications with a primary curve of 62 degrees and a lateral bending of 40 degrees.The patient was corrected to around 40 degrees and this poor correction may have contributed to the ratchet malfunction.Since the implant is not available for evaluation conclusion can not be determined.Risk assessment: the risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.1and 1.6) this event does not increase the probability rating.Besides, the company has implemented corrective action resulting in an updated design of the mid-c 125 of increase the strength of the ratchet spring (eco13 dms1213) the incident rate of ratchet malfunction following this mitigation stands at 1.26%( including the present case) and is in line with the rate of device-related adverse events ( 6.21% vs 15.5% reported in the literature.

Event Description

The follow-up x-ray on (b)(6) 2020 indicates on ratchet malfunction.

• Brand Name: MID-C 125 MM
• 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: 10818192
• MDR Text Key: 215578147
• Report Number: 3013461531-2020-00008
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

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 Expiration Date: 04/20/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 04-01-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Date Device Manufactured: 04/24/2017
• 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