MAUDE Adverse Event Report: SPINEFRONTIER INC P-LIFT

Model Number 14-06000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2018

Event Type  malfunction  

Manufacturer Narrative

The actual sample was not returned for evaluation.Spinefrontier investigation into this matter included design of an experiment using components from the same lot used to manufacture the complainant device.The failure mode inserter becomes disengaged during impaction was successfully re-created based on the following observation (knob loosening and eventually disengaging from the shaft component).Signs of wear was evident on both the shaft and knob components.However, the failure mode only replicated in scenarios when a worn knob was used with a new shaft, and in scenarios when over-tightening of the inserter onto the implant.The results of the experiment concluded that the failure was isolated to only the knob component and only occurred in scenarios where overtightening was a factor.A review of the current plift fmea revealed disassembly is known risks associated with the inserter with a rpn value of 6, which is less than actionable risk level.A review of the p-lift inserter labeling establishes there are adequate labeling with regards to over-tightening.Component wear is mitigated through pre/post-surgery inspection.

Event Description

Spinefrontier sales representative reported that the p-lift inserter disengage during impaction, there was no impact to patient as a result of this occurrence.

• Brand Name: P-LIFT
• Type of Device: P-LIFT
• Manufacturer (Section D): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• Manufacturer (Section G): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• Manufacturer Contact: josh harkess ; 350 main st; second floor; malden, MA 02148 ; 9782323990
• MDR Report Key: 8622120
• MDR Text Key: 145528206
• Report Number: 3005977257-2019-00009
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14-06000
• Device Lot Number: A41258MK-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Patient Outcome(s): Required Intervention