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

Catalog Number 86139

Device Problems Fracture (1260); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/18/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 285956820
• Report Number: 3012401682-2022-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290014064935
• UDI-Public: 7290014064935
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 86139
• Device Lot Number: SPGS385
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 80 KG