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

Catalog Number	86242-0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 14850100
• Report Number: 3012401682-2022-00003
• Device Sequence Number: 2380561
• Product Code: NKB
• UDI-Device Identifier: 07290014064980
• UDI-Public: 7290014064980
• 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 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): 06/29/2022

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 Catalogue Number: 86242-0
• Device Lot Number: 01074848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male