MAUDE Adverse Event Report: SYNTHES (USA) TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 45MM(37MM)

Catalog Number 487.228

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported there was a cervical spine locking plate removal.The original procedure was performed approximately 3-5 years ago; the hardware was explanted on (b)(6) 2013.The patient developed complication with the esophagus from prior surgery which warranted hardware to be removed.It was reported that the patient developed infection.Surgeons removed a two level small stature cervical spine locking plate at c3-c5 and a one level cervical spine locking plate at c6-c7.The patient requested to keep explants.The surgeons repaired the esophagus.The anterior cervical discectomy and fusion was from 3-5 years ago.The procedure was successfully completed with no patient injury.Plates and screws removed successfully.There was some difficulty while removing the hardware.One of the screws broke mid-way upon removal; the fragment was removed with heavy needle driver and removal instruments.There was no delay in the procedure.This is report 1 of 13 for complaint (b)(4).

Manufacturer Narrative

The investigation could not be complete; no conclusion could be drawn, as no product was received and no lot number was provided.(b)(6).Implant date: approximately 3-5 years ago; exact date unknown.Device was used for treatment, not diagnosis.Placeholder.

• Brand Name: TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 45MM(37MM)
• Manufacturer (Section D): SYNTHES (USA); 1302 wright lane east; west chester PA 19380
• Manufacturer Contact: tracy gutierrez ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3558023
• MDR Text Key: 16916577
• Report Number: 2520274-2014-00055
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 487.228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 67