FDA Adverse Event Malfunction Summary report: N

OSTEOTEC

MDR report key: 23877214 · Received December 23, 2025

Report

Report Number: 3008395366-2025-00846
Event Type: Malfunction
Date Received: December 23, 2025
Date of Event: March 16, 2023
Report Date: December 23, 2025
Manufacturer: OSTEOTEC LIMITED
Product Code: KYJ
PMA / PMN Number: K140453
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

OSTEOTEC HAS DETERMINED THAT HISTORICAL COMPLAINTS RELATING TO THE OSTEOTEC SILICONE FINGER IMPLANT SHOULD HAVE BEEN REPORTED AS AN MDR EVENT. WHILE SUBMITTING THIS REPORT AS A PRECAUTIONARY MEASURE, OSTEOTEC BELIEVES THE INCIDENT STEMMED FROM DAMAGE TO THE IMPLANT FROM FORCEPS, NOT A MATERIAL DEFECT IN THE MEDICAL GRADE SILICONE IMPLANT ITSELF. THE SURGICAL TECHNIQUE ADVISES SURGEONS "ATRAUMATIC FORCEPS SHOULD BE USED TO AVOID DAMAGING THE IMPLANT" TO ENSURE CORRECT FORCEPS ARE USED. DUE TO EXPLANTED DEVICE NOT BEING RETURNED, IT WAS NOT POSSIBLE TO CONDUCT A FULL INVESTIGATION. HAVING REVIEWED THE HISTORICAL RECORDS FOR THIS DEVICE, THERE ARE NO TRENDS THAT INDICATE THE DEVICE OR LOT HAVE ANY UNUSUAL CHARACTERISTICS. COMPLAINT TRENDING ACROSS THE OSTF PRODUCT FAMILY IDENTIFIED TWO OTHER FRACTURE COMPLAINTS ASSOCIATED WITH THE SAME 2021 MANUFACTURING ORDER; HOWEVER, NO SYSTEMIC MANUFACTURING, MATERIAL, OR DESIGN ISSUE WAS IDENTIFIED. NO NEW RISKS WERE IDENTIFIED, AND NO FURTHER REMEDIAL ACTIONS ARE REQUIRED AT THIS TIME. WE WILL CONTINUE ROUTINE POST-MARKET SURVEILLANCE AND TRENDING.

Description of Event or Problem · 0

DR (B)(6) REMOVED FRACTURED SILICONE FINGER IMPLANT FROM A PATIENT THAT FRACTURED WITHIN 2 WEEKS OF IMPLANTATION. THE IMPLANT WAS REPLACED WITH A SMITH & NEPHEW VOLAR IMPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2057286	OSTEOTEC	OSTEOTEC SILICONE FINGER IMPLANT	KYJ	OSTEOTEC LIMITED	OSTF-2	121906

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention