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

Model Number 60-000-35-09

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Code Available (3191)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was performed, and an issue was discovered within the product delivery process.Corrective measures have been performed, long term effectiveness verification will be performed to ensure corrective measures are acceptable.This is the first occurrence of this type of anomaly.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

Incorrect patient specific implant was delivered to hospital.Incorrect product was discovered in operating room prior to any surgery being performed.

• Brand Name: IPS
• Type of Device: PEEK IMPLANT
• 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: 7152535
• MDR Text Key: 96005889
• Report Number: 9610905-2017-00095
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00888118100375
• UDI-Public: (01)00888118100375
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 60-000-35-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Date Manufacturer Received: 11/30/2017
• 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