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 Problems Cerebrospinal Fluid Leakage (1772); Pain (1994)

Event Date 08/29/2022

Event Type  Injury  

Event Description

Patient # (b)(6) index procedure was performed on (b)(6) 2022.Apifix was notified that patient # (b)(6) was not discharged post operation until (b)(6) 2022 due to a cerebrospinal fluid (csf) leak. she had a ct done to confirm this.

Manufacturer Narrative

Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: patient (b)(6) index procedure was performed on (b)(6) 2022.Apifix was notified (on 04-oct-2022) that patient (b)(6) was not discharged post operation until (b)(6) 2022 due to a cerebral spinal fluid leak.She had a ct done to confirm this.On (b)(6) 2022 a blood patch procedure was performed, followed by 48 hours of strict flat bed rest, and the patient was discharged on (b)(6) 2022.Risk assessment: the risk of dural leak is a known risk.The event of dural tear/leakage is addressed in the ifu (dms-4472 rev g) as 'potential risks associated with the mid-c system and spine generally'.The current rate of this event is 0.30% and is in line with the rate (0.2%-2.2%) reported in the literature for this type of complication as described in the company's clinical evaluation report ( cer dms-727 rev u ).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Most csf leakages occur because of intraoperative dural tears.Although an adverse event has occurred, there does not appear to have been a problem with the device or the way it was used.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15697917
• MDR Text Key: 302699238
• Report Number: 3013461531-2022-00055
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

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 Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/31/2022
• Date Device Manufactured: 12/26/2021
• 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; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female