MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. OSTEOFAB CUSTOM DEVICE; CUSTOM ORTHOPEDIC IMPLANT

Model Number OFC0526-N

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

During implantation of a custom device that was requested and designed per physician prescription, the intramedullary stem fractured and the device was not used.Multiple device size options were provided for this case, and a different size device was successfully used to complete the surgery.The fractured device was discarded.

• Brand Name: OSTEOFAB CUSTOM DEVICE
• Type of Device: CUSTOM ORTHOPEDIC IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite rd.; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite rd.; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite rd.; south windsor, CT 06074 ; 8606569438
• MDR Report Key: 18817873
• MDR Text Key: 337663897
• Report Number: 3009582362-2024-00002
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 520(B) EX.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OFC0526-N
• Device Lot Number: 213526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2024
• 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): Other
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 29 KG