MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC OSTEOSET RESORBABLE MINI BEAD KIT FAST CURE 5CC; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	84000611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The patient underwent an "open reduction and internal fixation+bone grafting surgery" due to a fracture of the left tibial plateau.After the surgery, a small amount of exudate appeared in the wound on7 days later, showing a light yellow transparent liquid.Subsequently, the wound exudate gradually increased, showing a yellow pus color accompanied by the discharge of the artificial bone.It is considered that there is a rejection reaction after the artificial bone implantation.The patient is currently infected with the wound due to rejection reaction, and it is reported to the hospital, select sensitive drugs to resist infection based on secretion culture, and strengthen symptomatic treatment such as dressing changes.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient underwent an "open reduction and internal fixation+bone grafting surgery" due to a fracture of the left tibial plateau.After the surgery, a small amount of exudate appeared in the wound on 7 days later, showing a light yellow transparent liquid.Subsequently, the wound exudate gradually increased, showing a yellow pus color accompanied by the discharge of the artificial bone.It is considered that there is a rejection reaction after the artificial bone implantation.The patient is currently infected with the wound due to rejection reaction, and it is reported to the hospital, select sensitive drugs to resist infection based on secretion culture, and strengthen symptomatic treatment such as dressing changes.

• Brand Name: OSTEOSET RESORBABLE MINI BEAD KIT FAST CURE 5CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17504726
• Report Number: 3010667733-2023-00434
• Device Sequence Number: 6216822
• Product Code: MQV
• UDI-Device Identifier: 00840420133687
• UDI-Public: 00840420133687
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: Lay User/Patient
• Device Catalogue Number: 84000611
• Device Lot Number: 1729632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 Sex: Unknown