MAUDE Adverse Event Report: ALPHATEC SPINE INC ILLICO MIS POSTERIOR FIXATION SYSTEM; PEDICKE SCREW SYSTEM

Model Number	73865-40
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants are currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Revision surgery was conducted (b)(6) 2020 to extend the fixation from l4/5 to l3-l5 due to adjacent segment disease.While the surgeon tried to remove the implants, the id of the polyaxial screw was stripped/crushed and could not be removed.Eventually, after a 2 hour delay and alternative instrumentation, the surgeon was able to remove the implants.The illico mis posterior fixation system was originally implanted on (b)(6) 2015 at the l4/5.
Additional Manufacturer Narrative
Review of the device history records found no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released in accordance with the device master record.An evaluation of the returned polyaxial screw contained evidence that the screw removal tool had not been completely/securely engaged.The most proximal portion of the bone screws.140 deep internal hexalobe feature had rounded and worn edges while the majority of the distal section remained crisp and sharp as manufactured.This suggests that the tulip/head of the polyaxial screw required alignment to allow for clear engagement of the screw removal tool.Once aligned, the male hex of the removal tool and the female of the bone screw would properly mate and allow for extraction.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: PEDICKE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9910071
• Report Number: 2027467-2020-00022
• Device Sequence Number: 3375020
• Product Code: NKB
• UDI-Device Identifier: 00844856043190
• UDI-Public: (01)00844856043190(10)683043
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 73865-40
• Device Catalogue Number: 73865-40
• Device Lot Number: 683043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR