• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PREMIA SPINE LTD. PROMIS FIXATION SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMIS FIXATION SYSTEM
Type of DeviceORTHOSIS, 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 Key13548758
MDR Text Key285956820
Report Number3012401682-2022-00001
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07290014064935
UDI-Public7290014064935
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K150380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
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 Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number86139
Device Lot NumberSPGS385
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/17/2022 Patient Sequence Number: 1
-
-