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

Model Number 60-000-23-09

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

Patient Problem Impaired Healing (2378)

Event Date 03/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

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

Manufacturer Narrative

An investigation could not be performed because no device was returned, and it is unclear what stock number might have caused the problem as multiple devices were reported in the event.Review of the device history records was completed based on the product lot number identified.The dhr review showed no discrepancies or anomalies.It is unclear which stock number might have caused the problem, therefore complaint rate and review of the risk file were not performed.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Related reports: mdr 9610905-2019-00087, mdr 9610905-2019-00089, mdr 9610905-2019-00090, mdr 9610905-2019-00091.Mdr 9610905-2019-00092.

• Brand Name: IPS
• Type of Device: IMPLANT
• 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: 8432601
• MDR Text Key: 139204236
• Report Number: 9610905-2019-00088
• Device Sequence Number: 1
• Product Code: GXP
• 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
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• 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: 19000974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2019
• Date Manufacturer Received: 05/20/2019
• 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: 16 YR