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

Model Number	MID-C 105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional 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: on (b)(6) 2023 patient (b)(6) patient underwent a revision procedure, during which a broken screw was replaced, along with a shorter mid-c & a new extender.On (b)(6) 2023, patient (b)(6) was seen for a post-op visit. during  revision surgery on (b)(6) 2023, they cultured a film between the inner and outer sleeve of the mid-c.  after over 1 week, the anaerobic side grew p.Acnes (aka cutibacterium acnes).The patient was started on doxycycline 100 mg twice a day and scheduled for a follow up visit on (b)(6) 2023.No other issues or concerns were noted at the time.Risk assessment: the risk of late infection is a known risk that was assessed and recorded by the product risk management file.The current late infection rate is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk of infection is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally the risk has been quantified, characterized, and documented as acceptable within a full risk assessment.
Event or Problem Description
On (b)(6) 2023 patient (b)(6) patient underwent a revision procedure, during which a broken screw was replaced, along with a shorter mid-c & a new extender.On (b)(6) 2023, patient (b)(6) was seen for a post-op visit.During revision surgery ((b)(6) 2023) they cultured a film between the inner and outer sleeve of the apifix.After over one week, the anaerobic side grew p.Acnes.The patient was started on doxycycline 100 mg twice a day.

• Brand Name: MID-C 105
• Common Device Name: 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 street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16377317
• Report Number: 3013461531-2023-00002
• Device Sequence Number: 6381463
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-03-078-21
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/15/2023
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female