MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL); HXB

Model Number 87046-05

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the suspect device revealed no manufacturing or processing related irregularities.The instrument was found to be properly manufactured and released in accordance with design specifications.Visual inspection of the returned instrument found it had fractured and separated at the 40 mm depth grove indicator.A previous investigation for this type of event found that the instrument failed due to excessive lateral bending/fatigue stress related either to the patient or clinical factors/circumstances.

Event Description

While inserting into the pedicle, the tip broke.

• Brand Name: CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL)
• Type of Device: HXB
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7762124
• MDR Text Key: 116702215
• Report Number: 2027467-2018-00057
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00844856074057
• UDI-Public: (01)00844856074057(10)689328
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87046-05
• Device Catalogue Number: 87046-05
• Device Lot Number: 689328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other