MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 232-10-85-300

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The threads on the proximal end of the graft bolt that latch into the cage reportedly sheared off.The graft bolt went straight through the cage and wouldn't lock.The surgeon removed the graft bolt and implanted a screw that locked into the cage.

Manufacturer Narrative

The graft bolt has not returned for evaluation.Photographs were not provided.The identifying lot number was not provided; therefore, a review of the device history records could not be performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

• Brand Name: IDENTITI
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 17406780
• MDR Text Key: 319885998
• Report Number: 2027467-2023-00045
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190376369990
• UDI-Public: (01)00190376369990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203742
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232-10-85-300
• Device Catalogue Number: 232-10-85-300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1