MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS; PLATE

Model Number 60-000-23-09

Device Problems Device Issue (2379); Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00053, mdr 9610905-2018-00054.

Event Description

It was reported that after the patient received radiation the implant needs to be removed and replaced.Expected removal date (b)(6) 2018.

Manufacturer Narrative

An investigation was performed using a stereo microscope which revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.A review of the device history records was not possible due to no lot number identified.The investigation results conclude that the root cause cannot be determined since there was no failure found.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: IPS
• Type of Device: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 7506052
• MDR Text Key: 107962746
• Report Number: 9610905-2018-00052
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00888118100139
• UDI-Public: (01)00888118100139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 60-000-23-09
• Device Lot Number: 17007377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2018
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other