MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE); SPINE TRANSITION ROD

Catalog Number	03.75.897
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 4 april 2024: lot 1921821: (b)(4) items manufactured and released on 07-jun-2019.Expiration date: 2024-may-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 4 april 2024: must mini 03.75.849 must mini oc pre-bent transition rod 60° ø3.5/4x 200mm (ste) (k182837) lot 1921820: (b)(4) items manufactured and released on 07-jun-2019.Expiration date: 2024-may-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager: based on the event description, it was assumed that it was rather challenging to position the pre-bent rod into the screw head because of the transition area was too close to the screw head.The transition area is located 5mm under the radius, and it is long 5mm decreasing from ø4 to ø3.5mm.This area is intentionally identified in silver color to prevent both the radius and the transition zone from being matched to the connector of the oc plate.This latter is identified in gold color to ensure proper matching of the area ø4mm while preventing failure during the final tightening procedure.In the case of very particular anatomy, a straight transition rod is also available for contouring according to a specific patient's anatomy.Visual inspection was performed on the retrieved device with no evidence of abnormal aspects along the pre-curved shaft.
Event or Problem Description
Spinal fixation was performed at occipital bone-c2/c3.The surgeon had difficulty seating must mini oc pre-bent transition rod into the screw head at the right side of c2 (two rods with different angles were tried).The part he was trying to seat was silver and not gold, therefore he thought the diameter was 3mm, while it was more than 3mm and so could not be placed into the screw tulip.A straight rod was used to complete the surgery.About a 1-hour delay over a total surgery time of 4 hours and 30 minutes.The screw which was inserted at the c2 was ref:03.75.006,lot:1923635 and ref:03.75.006,lot:2227122.No problem on the left side of c2.

• Brand Name: MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
• Common Device Name: SPINE TRANSITION ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19178565
• Report Number: 3005180920-2024-00155
• Device Sequence Number: 17919613
• Product Code: NKG
• UDI-Device Identifier: 07630040723688
• UDI-Public: 07630040723688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2024
• Device Catalogue Number: 03.75.897
• Device Lot Number: 1921821
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2019
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian