MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: UNKNOWN
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9217626
• MDR Text Key: 169729062
• Report Number: 1526439-2019-52264
• Device Sequence Number: 1
• Product Code: JDN
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention