MAUDE Adverse Event Report: PREMIA SPINE LTD. PROMIS FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	86138
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records of the involved implant was performed and it was found that the lot was manufactured in accordance with specifications and no discrepancies were found.The explants were not obtained for investigation.However, there was no indication of hardware failure, the surgeon replaced only two screws with new longer premia spine screws and indicated that the loosening was due to spondylodiscitis.Screw loosening is a known complication in spinal fusion and in orthopedic surgeries in general and may be attributed to multiple factors including bone quality, patient's age and weight bearing forces.The rate of screw loosening in premia spine procedures is much lower than the rates reported in the literature for spine fusion procedures.Altogether, it is assumed that the loosening is related to the disease/technique rather than to a device failure.
Event or Problem Description
Patient implanted with the promis fixation system in germany, underwent a second revision surgery two months after the first revision due to another screw loosening.The original procedure was performed on (b)(6) 2023 due to stenosis and spondylodiscitis and included fusion at l5-s1.In the first revision surgery, two pedicle screws in s1 vertebra were replaced by two new larger diameter pedicle screws.L5 screws remained in-situ and rods were re-used.In the second revision surgery, two pedicle screws in s1 vertebra were replaced by two new longer pedicle screws.L5 screws remained in-situ and rods were replaced with new identical rods.According to the surgeon who performed both revision procedures, the reason for screw loosening was bone disease (spondylodiscitis).

• Brand Name: PROMIS FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer (Section G): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer Contact: elinor limor ; 7 giborey israel st.; ramat poleg; netanya, 42504-07 ; IS 4250407
• MDR Report Key: 18190215
• Report Number: 3012401682-2023-00007
• Device Sequence Number: 12566610
• Product Code: NKB
• UDI-Device Identifier: 07290014064928
• UDI-Public: 7290014064928
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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: 10/29/2023
• Device Catalogue Number: 86138
• Device Lot Number: SPGS366
• 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: 11/06/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG