MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE, 4 LEVEL, SIZE 72 (TI-6AL-4V- ELI); KWQ

Model Number 61004-072

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

While filtering the suctioned blood a spring from a 4 -level trestle anterior plate was located within the debris.The plate remains implanted.

Manufacturer Narrative

Initial information was provided by the user facility purchasing agent on (b)(4) 2014 which indicated a spring was found in suction blood at end of surgery.No additional details/information as to the product or implant were known or provided at the time.The name and contact information of a supervisor was given to alphatec customer service to obtain details of the event.Multiple contact attempts have gone unanswered.(b)(4) 2014 - alphatec customer services called and left message for supervisor.(b)(4) 2014 - alphatec customer services called and left message for supervisor.(b)(4) 2015 - alphatec compliance called (4 pm) and left message for supervisor.(b)(4) 2015 - alphatec compliance called (7:30 am) and left message for supervisor.(b)(4) 2015 - alphatec compliance called (5:45 am) and left message for supervisor.(b)(4) 2015 - alphatec compliance called and left message for supervisor.On 12/30/14 alphatec received the spring from the user facility which was identified as belonging to a trestle anterior plate.The spring is one of three components which make up the plates locking mechanism and function as one assembly.Because the spring is no longer attached to the implant it can be assumed that the locking mechanism is also no longer attached or functioning as intended.A trace of sales history was able to determine the part and lot number of the suspect device.Multiple attempts to obtain information to complete this report and/or to perform an investigation have gone unanswered.Upon the receipt of additional information a follow-up report will be submitted.

• Brand Name: ANTERIOR CERVICAL PLATE, 4 LEVEL, SIZE 72 (TI-6AL-4V- ELI)
• Type of Device: KWQ
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 4455343
• MDR Text Key: 15912286
• Report Number: 2027467-2014-00049
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 61004-072
• Device Catalogue Number: 61004-072
• Device Lot Number: 6336001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other