MAUDE Adverse Event Report: LIFE SPINE ARX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	175-035
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reproted that same post-op issue from the same t10-pelvis surgery on (b)(6) 2024.2-week post-op lateral x-ray shows that one tulip head disengaged at t10 and one bone screw at t10 pulled out with tulip attached and both screws at t11 and t12 being pulled out with tulips attached.
Additional Manufacturer Narrative
Prior to release, all arx modular tulip heads had been approved through life spine's quality control department and found to meet specifications.Based on the returned implants and the description of the reported event, it is hypothesized that the taper lock within the tulip head was not fully seated as rod reduction activites were performed.Which prevented the screwassembly from properly locking up.The taper lock experienced interference conditions that did not allow this seating condition to occur and the tulip head assembly dissociated from the bone screw with the same mechanical function as it was able to be intially assembled.The tulips not attached then put irregular forces on parts of the construct, leading to the condtion seen in the 2-week follow-up x-rays.Using a tulip priming device and/or investigating the potential interference conditions could help prevent this issue and a potential solution for future cases that require excessive reduction forces as it prepares the tulip head and taper lock into a proper position for lock down.

• Brand Name: ARX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 18960755
• Report Number: 3004499989-2024-00002
• Device Sequence Number: 15485340
• Product Code: NKB
• UDI-Device Identifier: 00190837168322
• UDI-Public: (01)00190837168322(10)KJ55
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220341D4846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 175-035
• Device Lot Number: KJ55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male