MAUDE Adverse Event Report: I.T.S. GMBH PELVIC RECONSTRUCTION SYSTEM

Model Number	21194-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of further investigation, we received the patient and surgery history and there it is stated that the fracture presented a non-union and thus the plate broke.
Event or Problem Description
Plating of a pubic branch fracture with a curved prs plate 10-hole.After six weeks the plate broke while using a wheeled walker.

• Brand Name: PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: PELVIC RECONSTRUCTION SYSTEM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 6696335
• Report Number: 3004369035-2017-00011
• Device Sequence Number: 19080698
• Product Code: HRS
• UDI-Device Identifier: 09120034302879
• UDI-Public: 09120034302879
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 21194-10
• Device Catalogue Number: 21194-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2016
• Initial Report FDA Received Date: 07/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other