MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 (DOUBLE PACKAGING); INTERVERTEBRAL BODY FUSION DEVICE ANTERIOR

Catalog Number 03.30.122

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This is the second revision surgery underwent by this patient.The patient had a primary using another company's product.The patient came in for a revision (unknown reason).The surgeon performed a revision using medacta product.The patient had a standalone alif at l4-s1.Then, the patient came in complaining of pain.On 16 june 2017 the (b)(4) performed a clinical evaluation and commented as follows: in a revision alif treatment, the supplemental vertebral screws were found broken few months after implantation.The reason for the failure cannot be determined with the information at hand.The supplied images do not allow to judge if the cage has moved from the original position, but it seems still located in a clinically efficient place.We do not know if the anterior vertebral shift is subsequent to screw fracture.Batch review performed on 26 june 2017.Lot 144088: (b)(4) items manufactured and released on 14 january 2015.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Not explanted yet.

Event Description

The patient came in complaining of pain.The surgeon noticed that the screws at l4 broke.The cause of the screw breakage is unknown.The surgeon planned to remove the broken screws and replace them with new screws.To date, the revision has not been scheduled yet.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 (DOUBLE PACKAGING)
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE ANTERIOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6680307
• MDR Text Key: 78793798
• Report Number: 3005180920-2017-00348
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 03.30.122
• Device Lot Number: 144088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2015
• 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: 52 YR