MAUDE Adverse Event Report: ALPHATEC SPINE, INC ILLICO MIS POSTERIOR FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	73865-45
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted upon completion of the device evaluation.
Event or Problem Description
A patient underwent a posterior lumbar fusion surgery at l3, l4, and l5 in (b)(6) 2017.An extension surgery took place in (b)(6) 2019 at t11-l5 and in (b)(6) 2020 at t11-s2a1 both using another manufacturers product.On (b)(6) 2021, a revision surgery was conducted to replace the implant.The surgeon used the head positioner to remove the screw because the screw head was locked.Once the screw was removed, it was found to have fractured, and the tip remained in the patient's vertebral body.The surgeon suggested the screw shank may have fractured prior to the revision surgery since there was no over-load during the removal process.The tip will be removed during a future revision surgery.No patient injury reported.
Additional Manufacturer Narrative
Corrected data: b3.(b)(6) 2021.D9.Yes.H3.Yes.Additional information: h6: medical device problem code: 1260.Component code:568.Type of investigation: 10; 3331.Investigation findings:3252.Investigation conclusion: 22.Review of device history records were conducted.No irregularities were identified during manufacturing or inspection.No trend of this nature has been detected.Device evaluation: engineering evaluation was provided on (b)(6) 2021.Visual inspect was conducted only proximal portion of screw was returned (approximately 19mm shank).Approximately 26mm still remain in patient.Screw shows no signs of mal use.Tulip head is locked (indicating proper rod lockdown in the illico system).Bone threads are not deformed or warped, suggesting that the screw was implanted properly and that failure did not occur during insertion.It is unknown if fusion had been achieved (3 revision surgeries since index surgery).These implants are intended for temporary stabilization until fusion occurs.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.7.Non-union and/or pseudarthrosis.Postoperative management: postoperative management by the surgeon, including instruction and warning and compliance by the patient, of the following is essential: 5.The illico mis posterior fixation system implants are designed and intended as temporary fixation devices.The devices should be removed after complete healing has occurred.Devices, which are not removed after serving their intended purpose may bend, dislocate, or break and/or cause corrosion, localized tissue reaction, pain, infection, and/or bone loss due to stress shielding.Complete postoperative management to maintain the desired result should also follow implant removal surgery.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12492615
• Report Number: 2027467-2021-00062
• Device Sequence Number: 16910987
• Product Code: NKB
• UDI-Device Identifier: 00844856043206
• UDI-Public: (01)00844856043206
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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?: Yes
• Device Model Number: 73865-45
• Device Catalogue Number: 73865-45
• Device Lot Number: 706688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2016
• Is the Device Labeled for Single Use? (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 Sex: Unknown