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

Model Number MID-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: at this time investigation is not possible since no information of the reoperation surgery was provided, when additional information will be available investigation will be done.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev q this complaint does not change the occurrences rate.

Event Description

The patient had a removal surgery on (b)(6) 2021 additional information is not available.

• Brand Name: MID-C
• 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: 12688638
• MDR Text Key: 278123045
• Report Number: 3013461531-2021-00038
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2021

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 Operator: No Information
• Device Model Number: MID-C
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/25/2021
• 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 Outcome(s): Required Intervention