MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD; ANTERIOR STAND-ALONE SPINE SCREW

Catalog Number	03.30.156
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2019.Lot 1822817: (b)(6) items manufactured and released on 14-mar-2019.Expiration date: 2024-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by r&d project manager: from the picture (x-ray), enclosed in the complaint, it's possible to see a broken screw in the s1 side.The direction of the broken screw is upside down refer to the correct direction.The potential root cause of the screw breakage is probably due to the contact between the alif screw and the pedicle screw already implanted into the patient.The impingement between the two screw generate an overload on the screw and the breakage of the screw itself.The not recovered piece of the screw is inside the implant window and, for this reason, it can be stated that the risk of migration is very low.In addition, it can be stated that the stability of the whole construct is safe even without the absence of one of the screw of the implant because it's already present a posterior fixation.Clinical evaluation performed by medical affairs director: in alif treatment of a secondary instability, one of the screws to lock the anterior lumbar cage broke during insertion.Part of the screw remained in the bone.There is no material problem related to this fragment.The alif cage should be able to perform in absence of one screw also because additional posterior fixation is provided.We cannot draw any definitive conclusion on the reasons that led to the fracture of the screw, with the information available.Another device was involved in the complaint, as it was revised during the surgery in which the above mentioned screw broke off: batch review performed on 20 may 2019.Mectalif posterior (ti peek) 03.27.035 posterior interbody fusion device peek/ti 11x22x12 l5°, lot 143952 (k133192): (b)(4) items manufactured and released on 11-may-2015.Expiration date: 2020-04-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary spine surgery on (b)(6) 2018.The patient revised due to pseudo-arthrosis at l5-s1 on (b)(6) 2019.The surgeon removed the mectalif posterior tipeek cage and implanted a mectalif anterior tipeek cage and mectalif anterior cage hybrid 14mm plate.Upon inserting the 5x30mm screw into the plate, the screw broke.The surgeon was able to remove the proximal portion of the screw but was not able to retrieve the distal portion of the screw.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
• Common Device Name: ANTERIOR STAND-ALONE SPINE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8636377
• Report Number: 3005180920-2019-00400
• Device Sequence Number: 13914492
• Product Code: OVD
• UDI-Device Identifier: 07630040727969
• UDI-Public: 07630040727969
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2024
• Device Catalogue Number: 03.30.156
• Device Lot Number: 1822817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention