MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL STANDARD ROTATIONAL

Model Number 15-8030/11

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Breakage of locking screw [pe plateau].

Event Description

Breakage of locking screw (pe plateau).

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: ENDO-MODEL STANDARD ROTATIONAL
• Type of Device: ENDO-MODEL STANDARD ROTATIONAL
• 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: 11782212
• MDR Text Key: 249202595
• Report Number: 3004371426-2021-00012
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 15-8030/11
• Device Catalogue Number: 15-8030/11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 05/01/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG