MAUDE Adverse Event Report: ALPHATEC SPINE, INC ALPHATEC NAVIGATION INSTRUMENTS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 19807-35-N

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

The instrument has not returned for evaluation.If additional information is provided, a supplemental report will be submitted.

Event Description

The tip of the tap, cervical, 3.5mm, navigation broke off in the vertebral body of the patient during surgery.It was unable to be retrieved and remains in-situ.

• Brand Name: ALPHATEC NAVIGATION INSTRUMENTS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 13031279
• MDR Text Key: 282483349
• Report Number: 2027467-2021-00079
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00190376309583
• UDI-Public: 00190376309583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153603
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 19807-35-N
• Device Catalogue Number: 19807-35-N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other