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

Model Number	PC12(39,10,1)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device had been implanted for a period of approximately 9 months before it was reported on (b)(6) 2023 that patient experienced swelling, soreness, pain and fluid accumulation.On (b)(6) 2024, revision surgery was performed to remove the device.During removal of device, the surgeon reported that device had showed signs of integration with surrounding soft tissue.Additionally, with use of endoscope, a small bump could be observed in the right nostril, none observed in the left nostril.Colourless fluid observed after cutting into bump.No clear signs indicating presence of infection reported by the surgeon.Currently, the patient is recovering well with no more complaints of pain.This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 3007303685-2024-00001 for the first device implanted in this patient.
Additional Manufacturer Narrative
This complaint was reported outside of the us market.This device model number is marketed in the us.The device was explanted on (b)(6) 2023 and returned to osteopore international for pathology evaluation.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.Histological investigation did not reveal any features of implant rejection and, although no bacteria were observed, an infective aetiology may have been possible.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.

• Brand Name: OSTEOMESH
• 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: 20459677
• Report Number: 3007303685-2024-00002
• Device Sequence Number: 7718467
• Product Code: GXP
• UDI-Device Identifier: 08885013200577
• UDI-Public: (01)08885013200577
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K051093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: 06/30/2025
• Device Model Number: PC12(39,10,1)
• Device Lot Number: 22-0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian