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

Model Number 116-4-5545

Device Problem Break (1069)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The implant has not returned for evaluation.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.If additional information is received, a supplemental report will be submitted.

Event Description

During an l4/l5 lif surgery, the amp bone screw broke in the patient at the l5 vertebral body.The screw shank was left in the patient and the screw head was recovered.

• Brand Name: AMP
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• 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: 14526932
• MDR Text Key: 293087145
• Report Number: 2027467-2022-00036
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190376205915
• UDI-Public: 00190376205915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191311
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 116-4-5545
• Device Catalogue Number: 116-4-5545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2022
• 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
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White