MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTA-C VARIABLE SELF-TAPPING SCREW DIAM. 4X16MM (2X); SPINAL BONE SCREW

Catalog Number	03.70.057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19july 2017.(b)(4).
Event or Problem Description
The patient came in complaining of bilateral numbness and pain.The surgeon noticed that 2 screws were broken.No trauma reported.The screws were broken in half.The surgeon revised the 2 variable screws.The surgeon implanted a longer plate and rescue screws to secure the plate.The surgery was completed successfully.X-rays and explants are not available.
Additional Manufacturer Narrative
On 29 august 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: based on the event i assumed that the patient underwent to a minor trauma and/or vertebra subsidence that could have potentially stressed the screws over the limit.However, it was reported that there was no trauma.The mechanical behaviour of the screws in term of mechanical resistance, was successfully tested during the validation phase to prove can resist physiological load: torsional and compression tests were performed on the final plate-screw construct to investigate about potential failure simulating the in vivo condition.All the test were performed according to the standards in force.From the visual inspection, we cannot determine the reason for this failure.

• Brand Name: MECTA-C VARIABLE SELF-TAPPING SCREW DIAM. 4X16MM (2X)
• Common Device Name: SPINAL BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6724690
• Report Number: 3005180920-2017-00387
• Device Sequence Number: 11013697
• Product Code: KWQ
• UDI-Device Identifier: 07630030840357
• UDI-Public: 07630030840357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 01/31/2021
• Device Catalogue Number: 03.70.057
• Device Lot Number: 1520527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/01/2017
• 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