MAUDE Adverse Event Report: LINKBIO CORP. CORE SHOULDER SYSTEM; CORE WORKSTATION

Model Number	87-9136
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation is ongoing.
Event or Problem Description
Two core workstations in inventory were found to have out-of-sync time/date.An engineer logged into the service account for each workstation to view the time and date displayed on the tablet's clock and they were observed to be out-of-sync by several months.An engineer then re-synced these workstations.

• Brand Name: CORE SHOULDER SYSTEM
• Common Device Name: CORE WORKSTATION
• Manufacturer (Section D): LINKBIO CORP.; 69 king street; dover NJ 07801
• Manufacturer (Section G): LINKBIO CORP.; 69 king street; dover NJ 07801
• Manufacturer Contact: deniz kortan ; 69 king street; dover, NJ 07801 ; 9736251333
• MDR Report Key: 24539180
• Report Number: 3006721341-2026-00004
• Device Sequence Number: 18398772
• Product Code: QHE
• UDI-Device Identifier: 00810022403099
• UDI-Public: (01)00810022403099
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K241470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87-9136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown