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

Model Number 60-000-78-09

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's bone fractured during implantation due to poor bone quality and the plate had to be removed the following day.Ifu (b)(4) contraindications list "insufficient or inadequate bone tissue".

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The product device history records were also reviewed based on the lot number provided, no anomalies were found.Due to no device being returned the root case for the failure cannot be determined.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: 7330125
• MDR Text Key: 102072790
• Report Number: 9610905-2018-00034
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 0088811810080
• UDI-Public: (01)0088811810080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062570
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 60-000-78-09
• Device Lot Number: C9622286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2018
• Date Manufacturer Received: 04/06/2018
• 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