MAUDE Adverse Event Report: ALPHATEC SPINE INC PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL); HXB

Model Number 22SPT10

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible.The instrument has not been returned for evaluation it was discarded by the user facility.Additionally, the identifying lot number has not been provided.The report indicated the instrument broke while attempting to insert into a level which contained previously implanted cement.Bone probes are designed to locate the proper pathway and length of the screw which is to be implanted.When used as intended the instrument would not come in contact with the amount of force required to fracture and/or deform the tip in this manner.

Event Description

Probe bent and broke while attempting to insert into a level in which cement had previously been placed.The event did not cause any patient harm.

• Brand Name: PEDICLE PROBE, LENKE CURVED (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: 7031211
• MDR Text Key: 92985949
• Report Number: 2027467-2017-00086
• Device Sequence Number: 1
• Product Code: HXB
• 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: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 22SPT10
• Device Catalogue Number: 22SPT10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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