MAUDE Adverse Event Report: APIFIX LTD. MID-C 85; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 85

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.On 08-sep-2023 apifix received a request from a distributor (italy) requesting an apifix surgical set for a planned removal surgery scheduled for (b)(6) 2023.Additional information was received on 13-sep-2023.According to the reporter, patient index surgery performed on (b)(6) 2014 in romania.Implants removed in italy due to pain in the back (surgeon told the reporter that 1 screw was in canal).Implants were sent to a partner hospital for evaluation of infected system.It takes 18 days for the implants to come back to the hospital where the reporter may come back to pick up for return to the manufacturer.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r; this complaint does not change the occurrences rate.At the time of this report, the incident rate for screw misplacement/migration was well within the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (cer).The event of screw misplacement/migration is addressed in the ifu (dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally.The explanted device is expected to been returned to the manufacturer and will be evaluated; upon its completion, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.

Event Description

On 10-sep-2023 apifix received a request from a distributor (italy) requesting an apifix surgical set for a planned removal surgery scheduled for (b)(6) 2023.According to the reporter, patient's index surgery performed on (b)(6) 2014 in romania.Implants removed in italy due to pain in the back (surgeon told the reporter that 1 screw was in canal).

• Brand Name: MID-C 85
• 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 street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17823104
• MDR Text Key: 324326297
• Report Number: 3013461531-2023-00046
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 85
• Device Catalogue Number: AFS-085-030
• Device Lot Number: AF-05-01-14
• Date Manufacturer Received: 09/08/2023
• Date Device Manufactured: 02/08/2021
• 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 Sex: Male