MAUDE Adverse Event Report: ALPHATEC SPINE INC XENON LUMBAR SPINAL FIXATION SYSTEM; HXB

Model Number	22SPT10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned lenke curved probe found the instrument had broken approximately 35mm from the distal tip.The 35mm location is the transition point where the 6.35mm diameter shaft tapers down to the distal tip.This location contains the smallest diameter on the instrument and is subject to the most stress during use.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.Additionally, the sales rep indicated the surgeon applied downward force while inserting.
Event or Problem Description
Probe broke in pedicle.The detached tip was removed without issue.

• Brand Name: XENON LUMBAR SPINAL FIXATION SYSTEM
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10526177
• Report Number: 2027467-2020-00039
• Device Sequence Number: 3144333
• Product Code: HXB
• UDI-Device Identifier: 00840967190112
• UDI-Public: (01)00840967190112(10)6505607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 22SPT10
• Device Catalogue Number: 22SPT10
• Device Lot Number: 6505607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other