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

Model Number MID-C 105 L

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 10/07/2020

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.Often, osteolysis can relate to the presence of a late-onset infection, apifix was just made aware of this incident and is collecting more information with which to determine a cause of the event.When new information is made available and a conclusion has been made, apifix will file a follow up mdr report.

Event Description

The patient has removal surgery of apifix system due to osteolysis of the proximal screw which migrated into the spinal canal.

• Brand Name: MID-C 105
• 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: 10818146
• MDR Text Key: 215583849
• Report Number: 3013461531-2020-00012
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/07/2021
• Device Model Number: MID-C 105 L
• Device Catalogue Number: AFL-105-040
• Device Lot Number: AF 09-01-16
• Date Manufacturer Received: 10/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention