MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

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 Description

This report is being filed after the subsequent review of the following literature article: at 4,5 year infection rate in open spondylodesis with decompression versus the less invasive lis technique in lumbar spine.Authors: pfandlsteiner t., wimmer c.Source: european spine journal.2010 nov; conference: 5th german spine conference- annual meeting of the german spine society.Bremen germany.Conference publication: (var.Pagings).19 (11) :1978.Deep infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); deep infection was evaluated.In all deep infections wide debridement, jet lavage, drainage was done, parenteral antibiotics 7 to 10 days by antibiogram and afterwards oral antibiotics were given.In deep infections in 3 cases s.Aureus, in 4 cases mrse, in 2 case e.Coli and in 1 case mrsa was found.Patient with deep infection needing revision (ae only ¿ expedium system) - in 1 unknown patient with staphylococcus aureus infection, a 2nd revision with debridement, jetlavage, surgical site drainage and antibiotics for 4 months was done.Superficial infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); superficial infection was evaluated.In superficial infections after revision parenteral antibiotics over 3 days, then oral antibiotics depending on the antibiogram were given.In superficial infections in 3 cases s.Aureus, in 1 case e.Coli and in 2 cases mrse was found.Device malfunction (malfunction only ¿ expedium screws) ¿ screw loosening - in unknown patients with open stabilizations; screw loosening was observed.

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT
• Type of Device: UNKNOWN
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7923528
• MDR Text Key: 122300968
• Report Number: 1526439-2018-50931
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: (01)UNKNOWN
• UDI-Public: (01)UNKNOWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other