MAUDE Adverse Event Report: ALPHATEC SPINE IDENTITI ALIF STANDALONE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 232-10-85-250;132-08342415-S

Device Problem Break (1069)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the graft bolt and the interbody spacer.Significant wear was observed on the distal threads of the graft bolt; this wear corresponds to large gouging in the posterior caudal end of the interbody spacer and in the inferior side of the medial bolt hole entry.The damage to the medial bolt hole and the posterior caudal endplate of the interbody spacer indicates that the graft bolt was driven at a considerably shallower angle than is indicated.As a result, the distal end of the graft bolt likely lodged in the porous titanium of the interbody spacer causing graft bolt torsional failure.Review of the device history records did not identify any manufacturing or processing related irregularities.The implants were found to be properly manufactured and released in accordance with design specifications.Labeling review: "possible adverse effects: possible adverse effects include: initial or delayed loosening, bending, dislocation, and/or breakage of device components.".

Event Description

During surgery, the graft bolt snapped in half.No patient injury reported.

• Brand Name: IDENTITI ALIF STANDALONE INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 150 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 13744446
• MDR Text Key: 287252851
• Report Number: 2027467-2022-00008
• Device Sequence Number: 1
• Product Code: OVD
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 232-10-85-250;132-08342415-S
• Device Catalogue Number: 232-10-85-250;132-08342415-S
• Device Lot Number: TO00378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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