MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW 7X45

Catalog Number 03.50.031

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Weakness (2145)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

Two pedicle screws and 2 cages (same sizes) were implanted during primary.To date, it is unknown which one of them has been explanted, for both pedicle screw and cage.On (b)(6) 2017 the (b)(6) manager performed a preliminary investigation and commented as follows: revision surgery.The surgeon replaced one of at least 4 screws previously implanted, and the interbody cage.This maneuver can be necessary in case of pedicle fracture or pedicle screw loosening.Pedicle fracture and pedicle screw loosening are well known complications in posterior spinal instrumentation surgeries with or without anterior cage support.Means that the event reported is a known complication with these types of pathologies treated with posterior instrumentation.No direct relationship to the medacta implants can be foreseen.Batch reviews performed on 20 january 2017.Pedicle screw 7x45, code 03.50.031, lot.155066 (k121115).(b)(4) items manufactured and released on 14 september 2015.Expiration date: 2020-08-17.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.Pedicle screw 7x45, code 03.50.031, lot.156699 (k121115).(b)(4) items manufactured and released on 23 november 2015.Expiration date: 2020-10-19.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.Mectalif posterior interbody fusion device peek/ti 11x25x10 l10°, code 03.27.048, lot.143958 (k133192).(b)(4) items manufactured and released on 26 february 2015.Expiration date: 2020-01-31.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.Mectalif posterior interbody fusion device peek/ti 11x25x10 l10°, code 03.27.048, lot.153234 (k133192).(b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-07-27.No anomalies found related to the problem.To date, 54 items of the same lot have been already sold without any similar reported event.Pedicle screw bent rod ti 5.5x35mm, code 03.50.450, lot.142266 (k121115).(b)(4) items manufactured and released on 18 november 2014.Expiration date: 2019-11-04.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.

Event Description

The patient fractured at l5, and was having pain and weakness.The surgeon removed one interbody 7x45mm pedicle screw, one cage and two rods.X-rays and explants are not available.

• Brand Name: M.U.S.T. PEDICLE SCREW 7X45
• Type of Device: PEDICLE SCREW
• 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 ; 91 6966060
• MDR Report Key: 6266443
• MDR Text Key: 65384425
• Report Number: 3005180920-2016-00754
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K121115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.50.031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR