MAUDE Adverse Event Report: SYNTHES GMBH PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/

Catalog Number 03.620.230

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the pedicle probe was unable to be locked at specified depth.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/ explanted.(b)(4).Investigation could not be completed and no conclusion could not be drawn as no device was returned.A review of the device history record was performed and no complaint related issues were found.Placeholder.

• Brand Name: PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: gary waikle ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3575646
• MDR Text Key: 4034128
• Report Number: 8030965-2013-05500
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.620.230
• Device Lot Number: 7595680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2011
• Is the Device Single Use?: No
• Patient Sequence Number: 1