MAUDE Adverse Event Report: SYNTHES ELMIRA ORACLE CAGE 50*22 H9 8° PEEK

Catalog Number 08.809.649S

Device Problem Positioning Problem (3009)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6); that during the surgery on (b)(6) 2013, the cage is hit very hard and stayed on the opposite side outside the vertebra, in a very difficult position to extract.Another cage is placed in the correct position.The first cage is left inside the patient without complications.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an implant.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of device history records was performed and no complaint related issues were found during manufacturing that would contribute to this complaint.Placeholder.

• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: gabriel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3562805
• MDR Text Key: 4211797
• Report Number: 3003506883-2013-00473
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K072791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dietician
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 08.809.649S
• Device Lot Number: 7298996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 22 YR