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

Catalog Number 86242-0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2022

Event Type  Injury  

Event Description

The company was informed about a supplemental fixation surgery of a promis system in (b)(6) due to degenerative disease in adjacent level.The surgeon indicated that the original surgery was at least 5 years ago and included l2/l3 fixation with the promis system and a cage, and that the reason for the subsequent surgery was common adjacent ddd and not implant related.In the supplemental fixation surgery additional microscopic decompression was performed, the rods were replaced with two 80mm promis rods and two pedicle screws were added, with a cage between l3/l4.No failure in the promis rods/screws or their positioning was indicated.The screws were intact and well positioned and not removed.The rods that were replaced were not returned and were therefore not available for further investigation.No additional information other than implant identification is available.

Manufacturer Narrative

Revision surgeries, including supplemental fixation, are commonly required after primary spinal fusion surgery.The company was notified of a supplement fixation surgery with additional company's promis system implants.No failure was indicated in the original procedure or in the explants at the time of removal and the pedicle screws were found intact and well positioned.Explants were not obtained for investigation.Review of the manufacturing records of the involved lot was performed and indicated it was manufactured in accordance with specifications without discrepancies.Furthermore, the rates of re-operation including supplemental fixation for the promis system is within the anticipated and reported rates in the literature for similar systems.Altogether, based on the available information, it is believed that the reason for the subsequent surgery was common adjacent ddd and is not related to the promis implants.

• 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: 14850100
• MDR Text Key: 294903292
• Report Number: 3012401682-2022-00003
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290014064980
• UDI-Public: 7290014064980
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 86242-0
• Device Lot Number: 01074848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male