MAUDE Adverse Event Report: SYNTHES BRANDYWINE ACF DETACHABLE TRIAL SPACER LORDOTIC 7MM

Catalog Number 396.923

Device Problem Sticking (1597)

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

Event Date 12/16/2013

Event Type  malfunction  

Event Description

It was reported on (b)(6 2013 that two anterior cervical fusion (acf) trial spacer handles (part # 396.989/lot # 8013959; part# 396.989/lot # 7732386) and a detachable trial space lordotic (part # 396.923/lot # 5240500) malfunctioned during surgery.The surgeon was performing an anterior cervical procedure when the first spacer handle got stuck.The surgeon then tried a second device and the second device got stuck as well.It is unknown as to which of the two devices got stuck to the acf detachable trial spacer lordotic.A third available spacer handle was used to successfully complete the surgery.No report of patient harm or injury was noted.No further information was provided as the sales consultant was not in on the case.It is unknown if surgery was delayed or not.No patient information was provided.This report is for one device, a acf detachable trial spacer lordotic.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

The device is an instrument, not implanted/explanted.Returned to manufacturer on (b)(4) 2013.Date received by manufacturer 12/16/2013.Device manufacture date 10/04/2006.A review of the device history record was completed; it indicated there were no anomalies which could have caused or contributed to this complaint.All records indicate the product was manufactured to specifications.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.Placeholder.

• Brand Name: ACF DETACHABLE TRIAL SPACER LORDOTIC 7MM
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: deidre adore ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3571890
• MDR Text Key: 4054816
• Report Number: 2530088-2013-01358
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 396.923
• Device Lot Number: 5240500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1