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

Model Number	PC22(13,13,5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Purulent Discharge (1812)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reported outside of the us market.This device model number is not marketed in the us market.However, the device is similar in material and manufacturing process to devices cleared to be marketed in us.The internal investigation into device production lot included a review of the reported information, review of the device history and complaint history records.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.In our investigations, there had been no other complaints reported against the same production lot.Additionally, review of complaint history records from year 2020 revealed no other complaints reported against similar device model number.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
Device implanted on (b)(6) 2023.On (b)(6) 2023, it was reported that the patient had pus.Information from surgeon on (b)(6) 2023: 1.Pus was found at the skin wound.2.Implant sent for culture.3.Wound was re-opened for washout.4.Antibiotics administered and completed.Patient is reported to be in stable condition now.It was reported on (b)(6) 2023 that test on culture showed presence of staphylococcus aureus.

• 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, singapore 61830-5 ; SN 618305
• MDR Report Key: 20490874
• Report Number: 3007303685-2024-00003
• Device Sequence Number: 17023940
• Product Code: GXP
• UDI-Device Identifier: 08885013201031
• UDI-Public: (01)08885013201031
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: PC22(13,13,5)
• Device Lot Number: 23-0120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian