MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE LP VERTEBRA T12; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	7.0412
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
My solution analysis m_fiu_ops_pc_11032000 (lot.02195s): our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
In the same case the surgeon wrongly inserted the myspine guide and the screws in an already instrumented level.Wrong position of t12 guide and then 4 screws were placed in t11.The wrong screws have been removed and replaced in the correct level.The next levels and screws have been correctly placed.

• Brand Name: MYSPINE LP VERTEBRA T12
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9361143
• Report Number: 3005180920-2019-00982
• Device Sequence Number: 19409612
• Product Code: LXH
• UDI-Device Identifier: 07630030877643
• UDI-Public: 07630030877643
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2020
• Device Catalogue Number: 7.0412
• Device Lot Number: 02195S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/22/2019
• 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
• Patient Age: 19 YR