MAUDE Adverse Event Report: APIFIX LTD MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 95

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.

Event Description

The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.

Manufacturer Narrative

First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.

Event Description

The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.

• Brand Name: MID-C 95
• 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: 12849772
• MDR Text Key: 285486753
• Report Number: 3013461531-2021-00039
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2021

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 Expiration Date: 05/17/2021
• Device Model Number: MID-C 95
• Device Catalogue Number: AF95
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/20/2021
• Date Device Manufactured: 05/17/2016
• 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