MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5.5X35; SCREW FOR INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 03.30.126

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The primary case was a l4-5 standalone alif.Additional information received on 06 february 2017 and includes: the surgeon plans to go posterior and does not have a date set.The patient went for a ct (no other information is available).On 17 february 2017 the medical affairs director performed a clinical evaluation and commented as follows: screw fracture in l5 in a patient treated for spondylolisthesis with standalone alif.The lateral image shows a visible space between screw and bone, indication that a significant overload was probably applied to the screw, resulting in fracture and probably loss of mechanical stability.The current situation of the patient is unknown; there is no report of traumatic event and the patient's weight was not reported.The cause for this event cannot be determined with the available information.Batch review performed on 28 february 2017.Lot 125106: (b)(4) items manufactured and released on 19 june 2013.Expiration date: 2018-04-30.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold and this is the second similar event reported on the lot.On 01 march 2017 the r&d project manager performed a preliminary investigation based on the x-rays received from the reporter and commented as follows: it could be see that there is a breakage of one of the screws inserted in l5-s1 just behind the plate.From the information, it's not clear if the breakage happen during the surgery or after the surgery.From the information received it is not possible to identify the route cause of the breakage of the screw, but it is compatible with an overload on the implant itself.Additional information received on 01 march 2017 and includes: the surgery was an anterior lumbar surgery, the surgeon has no need to perform invasive surgery to remove the screw if it is causing no harm to patient.Screw head is still locked into plate, the screw has good bone purchase, and there are 3 other screws stabilizing the construct.Screw did not back out, and is still fixated to bone.The patient does not have pain and patient is 100% fused as disc space.The surgeon thought he may need to do pedicle screw fixation posteriorly initially, but has no need to after reviewing mri.Not explanted.

Event Description

The patient came in complaining of pain.The surgeon noticed that the screw was broken.Initially, the surgeon planned an additional surgery to do pedicle screw fixation posteriorly.Then, after reviewing mri and since the patient had no more pain and achieved 100% disc fusion, the surgeon decided there was no need to proceed with a new surgery.X-rays are available.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5.5X35
• Type of Device: SCREW FOR INTERVERTEBRAL BODY FUSION DEVICE
• 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: 6372035
• MDR Text Key: 69164395
• Report Number: 3005180920-2017-00076
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 03.30.126
• Device Lot Number: 125106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2013
• 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): Other