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

Model Number 60-000-19-09

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

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2019

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 caused due to 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.Multiple mdr reports were filed for this event, please see associated report(s): mdr: 9610905-2019-00196; 9610905-2019-00197; 9610905-2019-00198.

Event Description

It was reported that product was removed due to patient condition.

• Brand Name: IPS
• Type of Device: CRANIAL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 9280132
• MDR Text Key: 165209908
• Report Number: 9610905-2019-00195
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00888118100054
• UDI-Public: (01)00888118100054
• 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
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-000-19-09
• Device Lot Number: 8000012586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2019
• Date Manufacturer Received: 10/15/2019
• 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
• Patient Age: 20 YR
• Patient Weight: 90