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

Catalog Number	86139
Medical Device Problem Codes	Fracture (1260); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the description of the event, including ct images and an evaluation of the retrieved implants (pedicle screw head and rods), we surmise that the reported event is attributed to irregular fatigue created due to prominent iliac crest that was not removed in the original procedure.This prevented proper rod placement and tightening of the s1 pedicle screw's set screw which led to movement of the rod within the pedicle screw head and eventually caused breakage of the screw.Review of the manufacturing records of the involved implants was performed and it was found that the lots were manufactured in accordance with specifications and no discrepancies were found.In addition, occurrence of premia spine's pedicle screw breakage is lower than the rate reported in the literature.Thus, the cause of the event is concluded to be related to the surgical technique and is not device related.If additional information becomes available, a follow up report will be submitted.
Event or Problem Description
The company was informed about a revision surgery in (b)(6) of a promis system scheduled for (b)(6) 2022 due to patient complaints of pain and noises from her back.During the surgery, surgeon determined that fusion was achieved and the instrumentation was removed.Upon removal of the pedicle screws, one pedicle screw in s1 was found broken.The pedicle screw head was retrieved, and the screw body remained in-situ.The surgery was successfully completed and the patient is doing well.

• 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: 13548758
• Report Number: 3012401682-2022-00001
• Device Sequence Number: 12061933
• Product Code: NKB
• UDI-Device Identifier: 07290014064935
• UDI-Public: 7290014064935
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 06/30/2024
• Device Catalogue Number: 86139
• Device Lot Number: SPGS385
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2019
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 80 KG