MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

Catalog Number	03.65.707
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2019: lot 1720491: 80 items manufactured and released on 28-mar-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.Addition implants involved in the event: sacro-iliac screw system 03.65.704 si-joint screw 10x40 (k171595) lot.1720488.Batch review performed on 08 october 2019: lot 1720488: 47 items manufactured and released on 09-apr-2018.Expiration date: 2023-03-19.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any similar reported event.Two devices of this lot involved in this complaint.Addition implants involved in the event: sacro-iliac screw system 03.65.903 standard washer ø17mm, ti (k171595) lot.1720499.Batch review performed on 08 october 2019: lot 1720499: 58 items manufactured and released on 09-apr-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, 41 items of the same lot have been already sold without any similar reported event.Two devices of this lot involved in this complaint.Addition implants involved in the event: sacro-iliac screw system 03.65.901 standard washer ø13mm, ti (k171595) lot.1720497.Batch review performed on 08 october 2019: lot 1720497: 72 items manufactured and released on 09-apr-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 9 months after primary the surgeon decided to revise the implants for loosening in the sacrum.Explantation was difficult and caused a lot of muscular damage.

• Brand Name: SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55
• Common Device Name: SACRO-ILIAC SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9165880
• Report Number: 3005180920-2019-00862
• Device Sequence Number: 18934738
• Product Code: OUR
• UDI-Device Identifier: 07630030881114
• UDI-Public: 07630030881114
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 03/20/2023
• Device Catalogue Number: 03.65.707
• Device Lot Number: 1720491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/08/2019
• 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: 65 YR