MAUDE Adverse Event Report: OSTEOPORE INTERNATIONAL PTE LTD OSTEOPLUG; BONE FILLER

Model Number	PC22(14,14,4)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reported outside of the us market.This device model number is marketed in the us.The explanted device was not returned to osteopore international.A third-party laboratory analysed the histology samples.The internal investigation into device production lot included a review of the reported information, review of the device history and complaint history records, and analysis of the returned biopsy specimens.Review of device history record(s) showed no issues during the manufacture of this device.No non-conformity was identified in the review of the following records: production record, sterilization record, certification of irradiation.Searching our complaint database, there had been no other complaints reported against the same production lot or part number.The histology report suggests that the patient might have suffered from a rare case of hypersensitivity to device material.From the review of device labelling, the risks related to allergies and other reactions to device material had already been highlighted.This appears to be an isolated event and no other incident has occured.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
Surgeon reported that patient has an aesthetically disturbing bump on the forehead.Mri scan (performed on (b)(6) 2022) and ct scan (date unknown) were taken and it was medically concluded that patient was not suffering from any form of infection.There was also no bone formation at the implant site.A surgical intervention was performed on (b)(6) 2022 to remove the device.This complaint is associated with the first of 2 devices implanted in this patient.Refer to medwatch 3007303685-2024-00005 for the second device implanted in this patient.

• Brand Name: OSTEOPLUG
• Common Device Name: BONE FILLER
• Manufacturer (Section D): OSTEOPORE INTERNATIONAL PTE LTD; 2 tukang innovation grove; #09-06 jtc medtech hub; singapore, singapore 61830 5; SN 618305
• Manufacturer (Section G): OSTEOPORE INTERNATIONAL PTE LTD; 2 tukang innovation grove; #09-06 jtc medtech hub; singapore, singapore 61830 5; SN 618305
• Manufacturer Contact: ammar hassanbhai ; 2 tukang innovation grove; #09-06 jtc medtech hub; singapore, 61830-5 ; SN 618305
• MDR Report Key: 20531071
• Report Number: 3007303685-2024-00004
• Device Sequence Number: 15569623
• Product Code: GXP
• UDI-Device Identifier: 08885013201383
• UDI-Public: (01)08885013201383
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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 Expiration Date: 02/28/2023
• Device Model Number: PC22(14,14,4)
• Device Lot Number: 20-0468
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2021
• 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 Age: 43 YR
• Patient Sex: Male