MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H 12MM

Catalog Number 03.802.019

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/21/2012

Event Type  malfunction  

Event Description

A complaint was received from a consultant in regards to an alif stating; as the surgeon was using the synfix(tm)-lr trial impl 12de, the tip broke off, leaving the trial spacer in the intervertebral space.The surgeon was able to remove the trial spacer from the patient.The tip is still in the trial spacer.Surgery was completed without further incident and no adverse effect to the patient was noted.This is report 1 of 1 for complaint #(b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device was used for treatment, not diagnosis.Manufacturing records were reviewed and no complaint related issues were found.Placeholder.

• Brand Name: SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H 12MM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4345656
• MDR Text Key: 5216496
• Report Number: 8030965-2014-01822
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.802.019
• Device Lot Number: 2337691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2012
• Date Device Manufactured: 04/09/2008
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H