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

Model Number MID-C 125

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

Patient Problem Bacterial Infection (1735)

Event Date 12/03/2020

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.User (surgeon) information analysis: the x-ray demonstrates extender misalignment with the mid-c rod in the current case, the loss of correction was related to misuse: 1.The distance between the polyaxial joint and the extender screw was not per the surgical technique.2.The angle between the extender and rod was greater than 5-15 degrees as instructed in the surgical technique to prevent such cases, apifix already implemented corrective actions: 1.Issued a letter to all surgeons instructing on the rod/extender angle required 2.Designed a pre-bend extender to aid in reaching the desired rod/extender angle (eco-48) 3.Implemented a new instrument, "extender-main rod angle measurement" (eco-063), that helps the surgeon adjust the angle between the mid-c main rod and the extender within a range of 5 to 15 degrees.The present case was performed post the first corrective action (surgeon letter) and previous 2 and 3 corrective action.Patient reoperation finding: the surgeon planned to replace the mid-c system with a bigger construction to gain more correction of the curve on (b)(6) 2020 during the extraction of the mid-c system, the surgeon observed an unknown tissue and white liquid that similar to an infection.The surgeon took a culture test, performed jet lavage irrigation, placed local antibiotics, and closed the surgical field without placing a new implant.Risk assessment: at the time of this report (dec 7 2020), the company's incident rate of extender misalignment following mitigation 1 and 2 is 4.43% and 0% following mitigation #3.The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable (dms#777 rev q1 hazard id 22.8) late-onset infection is a known risk which was assessed and recorded by the product risk assessment dms-777 rev q hazard id 21.5 this complaint does not change the occurrences rate.The rates of late infection before apifix recommendation of applying vancomycin powder is 5.8% and 0% after applying this recommendation.The company is closely monitoring eco 63 mitigation effectiveness.

Event Description

The paitent will have revision surgery due to loss of curve correction.

• 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: 11075563
• MDR Text Key: 223703134
• Report Number: 3013461531-2020-00019
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/24/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 10-01-17
• Date Manufacturer Received: 12/03/2020
• Date Device Manufactured: 10/24/2017
• 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