MAUDE Adverse Event Report: MERETE GMBH PEDIATROS RIGIDTACK; BONE STAPLE

Model Number	CP20130
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has been implanted with rigidtack staples to slow down his growth.To treat a genu varum the staples on one side of the leg have been removed.By that the staples started to bend and dislocate.Hence that the staples have been removed.

• Brand Name: PEDIATROS RIGIDTACK
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12247 , GM; GM 12247, GM
• MDR Report Key: 14274409
• Report Number: 3012147813-2022-00004
• Device Sequence Number: 5907592
• Product Code: OBT
• UDI-Device Identifier: 04048266138279
• UDI-Public: 04048266138279
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2017
• Report Date (Section F): 01/29/2018

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: Lay User/Patient
• Device Model Number: CP20130
• Device Catalogue Number: CP20130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male