MAUDE Adverse Event Report: OSTEOTEC LIMITED SILICONE FINGER IMPLANT - SIZE 4; OSTF-4

Model Number	OSTF-4
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales manager reported on 05nov2025 that an ostf-4 had to be removed due to the implant breaking.It was stated that the initial case took place on (b)(6) 2025 but needed revision surgery on (b)(6) 2025.The surgeon ultimately implanted a second ostf-4 with no issue.The surgeon was not upset about the implant and tried to collect information if the patient fell or what happened, however, there was no additional information provided by the patient.A photograph of the fractured implant was provided, and the device has been made available for return and evaluation.At this stage, no further investigation or failure analysis details are available.Additional information will be submitted in a supplemental mdr if received.

• Brand Name: SILICONE FINGER IMPLANT - SIZE 4
• Common Device Name: OSTF-4
• Manufacturer (Section D): OSTEOTEC LIMITED; building 81 greenham business; newbury, thatcham RG19 6HW; UK RG19 6HW
• Manufacturer (Section G): OSTOTEC LIMITED; building 81 greenham business; newbury, thatcham RG19 6HW,; UK RG19 6HW,
• Manufacturer Contact: james norman ; building 81 greenham business; newbury, thatcham RG19 -6HW ; UK RG19 6HW
• MDR Report Key: 23729737
• Report Number: 3008395366-2025-00316
• Device Sequence Number: 21473325
• Product Code: KYJ
• UDI-Device Identifier: 05060183090057
• UDI-Public: 05060183090057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: OSTF-4
• Device Lot Number: 121912
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown