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 Wound Dehiscence (1154)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

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.Patient (b)(6) index procedure was performed on (b)(6) 2022.During monitoring, as part of the pas study, apifix identified from patient (b)(6) medical records that on (b)(6) 2022 a wound complication (dehiscence) was identified, a culture was obtained.The patient was hospitalized for spine wound exploration, irrigation, debridement and wound closure following the dehiscence.Iv ancef antibiotics were given.The patient was discharged the next day.The risk of wound complication is a known risk.The event of wound complication is addressed in the ifu (dms-4472 rev g) as potential risks associated with the mid-c system and spinal surgery generally section.The current rate of this event is well 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 has been quantified, characterized, and documented as acceptable within a full risk assessment.

Event Description

Patient (b)(6) index procedure was performed on (b)(6) 2022.During monitoring, as part of the pas study, apifix identified from patient (b)(6) medical records that on (b)(6) 2022 a wound complication (dehiscence) was identified, a culture was obtained.The patient was hospitalized for spine wound exploration, irrigation, debridement and wound closure following the dehiscence.Iv ancef antibiotics were given.The patient was discharged the next day.

• 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: 15758142
• MDR Text Key: 303295976
• Report Number: 3013461531-2022-00059
• 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: Study,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2022

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: 10/13/2022
• Initial Date FDA Received: 11/09/2022
• Date Device Manufactured: 12/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female