MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION SYSTEM; FIXATION SCREW, INCL. 2 UHMWPE LOCK BOLTS, UHMWPE, COCRMO L= 58 MM

Model Number	172-945/58
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Loose expansion screw and neck segment.[customer, translated from german].
Event or Problem Description
Loose expansion screw and neck segment.[customer, translated from german].
Additional Manufacturer Narrative
After final examination, it was decided to specify the fixation screw (article number 172-945/58) as the main component of this complaint.This is the final supplemental report, the complaint is closed.

• Brand Name: MP RECONSTRUCTION SYSTEM
• Common Device Name: FIXATION SCREW, INCL. 2 UHMWPE LOCK BOLTS, UHMWPE, COCRMO L= 58 MM
• 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: 18892430
• Report Number: 3004371426-2024-00025
• Device Sequence Number: 6410734
• Product Code: JDI
• UDI-Device Identifier: 04026575203048
• UDI-Public: 04026575203048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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 Model Number: 172-945/58
• Device Catalogue Number: 172-945/58
• Device Lot Number: 0052021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 88 YR
• Patient Sex: Male