MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION SYSTEM; NECK SEGMENT, WITH SUTURE HOLES, STANDARD, UNCEMENTED, L= 35 MM, CCD 126°

Model Number	99-0984/32
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A recall of affected devices will be conducted under r-2024-09.
Event or Problem Description
The labels (main label as well as patient label) indicate a size xxl, although this is a standard-size neck segment.
Additional Manufacturer Narrative
The recall r-2024-09 was initiated and all affected devices have been removed from the us market.This is the final supplemental report, the complaint is closed.
Event or Problem Description
The labels (main label as well as patient label) indicate a size xxl, although this is a standard-size neck segment.

• Brand Name: MP RECONSTRUCTION SYSTEM
• Common Device Name: NECK SEGMENT, WITH SUTURE HOLES, STANDARD, UNCEMENTED, L= 35 MM, CCD 126°
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20785194
• Report Number: 3004371426-2024-00077
• Device Sequence Number: 18400223
• Product Code: JDI
• UDI-Device Identifier: 04026575409785
• UDI-Public: 04026575409785
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 99-0984/32
• Device Catalogue Number: 99-0984/32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: Other
• Patient Sex: Unknown