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

Model Number 233-150

Device Problem Fracture (1260)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

During an anterior lumbar interbody fusion surgical procedure, the distal end of the inserter broke off while the surgeon was malleting the spacer during insertion.The broken piece was retrieved.There were no patient symptoms or complications reported as result of this event.

Manufacturer Narrative

The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

Manufacturer Narrative

Corrected data: h6: medical device problem code: 1562.Device evaluation: h6: investigation findings: 3251.Investigation conclusions: 22.H10: visual inspection of the device confirmed the distal arm had detached and separated from the shaft.The distal arm was not returned with the device.Review of the device history record indicates the device conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The arm of the inserter is a subcomponent which features an ipsilateral prong that attaches to the interbody spacer for insertion.This type of damage is consistent when force is applied during impaction/insertion of the interbody spacer causing the distal arm to detach from the shaft.Labeling review: "warnings/cautions/precautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudoarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury." "possible adverse effects: possible adverse effects include: initial or delayed loosening, bending, dislocation, and/or breakage of device components.".

• Brand Name: IDENTITI ALIF
• 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: wesely channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18069695
• MDR Text Key: 327535759
• Report Number: 2027467-2023-00072
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190376382982
• UDI-Public: (01)00190376382982(10)EM46681
• 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,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 233-150
• Device Catalogue Number: 233-150
• Device Lot Number: EM46681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• 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