MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PYROCARBON HRA SZ. 50/21; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number CRA9105021WW

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a tsa surgery was performed on (b)(6) 2012, the patient experienced fracture of the implant.This adverse event was treated by a revision surgery on (b)(6) 2020, in which a pyrocarbon hra sz.50/21 was exchanged.Patient's current health status is unknown.

Manufacturer Narrative

H11: this complaint has been reassessed based on the existing information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21cfr803 regulations.The alleged device pyrocarbon hra sz.50/21 (b)(6) is distributed only in the australian market.

• Brand Name: PYROCARBON HRA SZ. 50/21
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16957667
• MDR Text Key: 315532197
• Report Number: 3002788818-2023-00038
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00885556831168
• UDI-Public: 885556831168
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRA9105021WW
• Device Lot Number: 09-2121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male
• Patient Weight: 85 KG