MAUDE Adverse Event Report: AAP IMPLANTATE AG STRAIGHT PLATE WSP 2.5, 8 HOLES, L75; BONE PLATE

Model Number PG 2540-08-2

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Failure of Implant (1924)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

Breakage of angle stable plate one week after surgery.Medical intervention necessary.The plate has been used for an ulna fracture.

Manufacturer Narrative

The plants has been used for a fracture of the ulna.This kind of indication is not mentioned in the instructions for use and therefore an off-label use.The tests performed by aap did not include an evaluation of the plate for ulna fractures.Unfortunately no further information regarding the incident has been forwarded to aap.Therefore no more additional tests have been initiated so far.Depending on further information like x-rays aap will decide if further tests are necessary.Until today the conclusion is that the breakage occurred because of the off-label use.

• Brand Name: STRAIGHT PLATE WSP 2.5, 8 HOLES, L75
• Type of Device: BONE PLATE
• Manufacturer (Section D): AAP IMPLANTATE AG; berlin ; GM
• Manufacturer Contact: marc seegers ; lorenzweg 5; berlin 12099 ; GM 12099 ; 307501192
• MDR Report Key: 4483125
• MDR Text Key: 5345633
• Report Number: 8043862-2015-00001
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PG 2540-08-2
• Device Lot Number: I003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2009
• 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