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	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lot was performed and indicated that it was manufactured in accordance with company specifications.The explants have been returned and investigated.It was found that in both explants, the screw body was broken near the screw head while the screw head remained captured inside the tulip.Since there are no available imaging of the patient or other clinical information, it is difficult to determine the reason for screw breakage.Occurrence of premia spine's pedicle screw breakage (less than 1%) is lower than the average rate reported in the literature which ranges up to 21%.Furthermore, the current revision rates associated with the promis system is within the anticipated and reported rates in the literature for similar systems.If additional information becomes available, a follow up report will be submitted.
Event or Problem Description
The company received two broken pedicle screws that were explanted in a revision surgery of the promis system in the us.The explants arrived in a plastic container, labeled with the patient initials and date of birth which allowed traceability to the original procedure.The original procedure was performed on 02.05.2016 and was a 5-level fusion from l2 to s1.The involved screws (7.5x45mm) were implanted in the s1 level.No additional information is available regarding the original or revision surgeries, patient's clinical background and other relevant clinical information despite multiple attempts to receive information from the surgeon who performed the index and revision surgeries.

• 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: 16795535
• Report Number: 3012401682-2023-00001
• Device Sequence Number: 14265970
• Product Code: NKB
• UDI-Device Identifier: 07290014064928
• UDI-Public: 7290014064928
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K150380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 02/28/2021
• Device Catalogue Number: 86138
• Device Lot Number: SPG0278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female