MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CLSD ILIAC CN 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179798100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is a revision case report.The 8 mm screw and iliac connector from the right side were removed due to protrusion which resulted in penetration of the skin of the patient and infection.The primary surgery was done in (b)(6) 2019.The patient has lost 20 kg of body weight in the last 5 months and is a heavy smoker.The protrusion of the screw was not evident at the time of the surgery.The products involved had to be left in the hospital for sterilization (code 1997-21-8xx and 1997-21-000) and might be returned for analysis if the hospital allows.I will have that information on monday, 30th september.Code 1797-98-100 will not be returned as it will be used for analysis of the infection (sonification).This complaint involve three (3) devices.

• Brand Name: 5.5 TI CLSD ILIAC CN 100MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9217630
• Report Number: 1526439-2019-52263
• Device Sequence Number: 19378926
• Product Code: NKB
• UDI-Device Identifier: 10705034083032
• UDI-Public: (01)10705034083032
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179798100
• Device Catalogue Number: 179798100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/22/2019
• 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