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

Model Number	60-000-23-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported the implant did not fit as expected.Surgery was completed with alternate product.
Additional Manufacturer Narrative
A stereo microscope investigation revealed that the returned device was cut in to pieces.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.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.Due to the device being cut in to pieces the root cause for the failure cannot be determined.

• Brand Name: IPS
• Common Device Name: IMPLANT
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8121218
• Report Number: 9610905-2018-00322
• Device Sequence Number: 19253104
• Product Code: GXN
• UDI-Device Identifier: 00888118100139
• UDI-Public: (01)00888118100139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018
• Report Date (Section F): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-000-23-09
• Device Lot Number: 8000001540
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1