MAUDE Adverse Event Report: INTEGRA YORK, PA INC. DECKER MICRO RONGEUR 5.5 STR; NONE

Catalog Number 285110

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/29/2013

Event Type  Injury  

Event Description

Customer medwatch not provided.Customer reports that during a procedure a piece of a ronguer 8mm broke off, fell inside patient and became embedded within the soft tissue, deep against the vertebral body.X-rays were done.Physician was unable to retrieve the metal piece.The neuro surgeon fell it was safer to leave it inside patient to avoid a dura leak.Numberous contacts with customer but not forth coming with any more information.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.(b)(4).

• Brand Name: DECKER MICRO RONGEUR 5.5 STR
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer Contact: schlossackerweg 611; balgheim ; 424958260
• MDR Report Key: 4648633
• MDR Text Key: 5682658
• Report Number: 8010282-2015-00001
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 285110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 41 YR