MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS CANAL FILLING STEM 19MM X 152MM, BOWED SLOTTED, SPLINED

Model Number	FB-19152-03M
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised due to an eleos canal filling stem which loosened over time.The patient's index surgery was on (b)(6) 2019, where the patient was implanted with the canal filling stem, a male-female midsection, and a custom adaptor.The patient was revised on (b)(6) 2022 to remove and replace the canal filling stem and male-female midsection.The custom adaptor was left implanted.This event will be reportable to the fda as a serious injury due to the revision procedure.No alleged issues occured with the male-female midsection and the custom adaptor; therefore, these devices are concomitant.
Event or Problem Description
It was reported that a patient was revised due to an eleos canal filling stem which loosened over time.The patient's index surgery was on (b)(6) 2019, where the patient was implanted with the canal filling stem, a male-female midsection, and a custom adaptor.The patient was revised on 19 april 2022 to remove and replace the canal filling stem and male-female midsection.The custom adaptor was left implanted.This event will be reportable to the fda as a serious injury due to the revision procedure.No alleged issues occured with the male-female midsection and the custom adaptor; therefore, these devices are concomitant.
Additional Manufacturer Narrative
It was reported that a patient experienced loosening of an eleos canal filling segmental stem.The patient was revised on 19 april 2022, to remove and replace the loosened canal filling segmental stem.The surgeon revised the 19x152mm canal-filling bowed segmental stem to a 21x152mm canal-filling bowed segmental stem.During the revision procedure, the eleos male-female midsection was revised as well.There were no alleged issues reported with the male-female midsection; therefore, this device will be considered concomitant.A review of the work order and sterilization batch release record for the product involved found no indication that the implant loosening was a result of a manufacturing or sterilization nonconformance.A complaint trend was not identified.The root cause for the canal-filling segmental stem loosening could not be determined.Based upon the review of the device history records and sterilization records, the investigation concluded that the root cause of the canal-filling segmental stem loosening was not related to the design, manufacturing, and/or sterilization of the components.The root cause of the canal-filling segmental stem loosening could not be determined.From the submitted intake form, it was reported that the patient was compliant and had medium activity levels, however, the patient had poor bone quality.It is possible that loosening could have occurred due to insufficient healing, residual post-operative motion, etc.However, a root cause could not be determined based on the available information.

• Brand Name: ELEOS
• Common Device Name: ELEOS CANAL FILLING STEM 19MM X 152MM, BOWED SLOTTED, SPLINED
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14453887
• Report Number: 3013450937-2022-00166
• Device Sequence Number: 14596321
• Product Code: KRO
• UDI-Device Identifier: B278FB1915203M0
• UDI-Public: B278FB1915203M0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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 Expiration Date: 03/04/2016
• Device Model Number: FB-19152-03M
• Device Catalogue Number: FB-19152-03M
• Device Lot Number: 82299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25001050E, LOT 1791867. MALE-FEMAL MIDSECTION.; P/N 25001050E, LOT 1791867. MALE-FEMAL MIDSECTION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male