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

Model Number 60-000-23-09

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.Based on the information provided the most likely root cause is patient condition.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

Event Description

Peek implant was removed to address patient infection.

• Brand Name: IPS
• Type of Device: IPS
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 9498324
• MDR Text Key: 172092923
• Report Number: 9610905-2019-00233
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00888118100139
• UDI-Public: (01)00888118100139
• Combination Product (y/n): N
• PMA/PMN Number: K072707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/29/2019

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 Model Number: 60-000-23-09
• Device Lot Number: 8000005319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2019
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other