MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - VEPTR IMPLANTS; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: studer, d., trampuz, a., hasler, c., plaar, c.(2010), infection rate of expandable, distraction spine implants in children with severe spine and thoracal deformities, eurpean spine journal, vol.19, page 1995 (germany).The aim of this study was to analyze the total number of infections, identify potential precursors and the relevance of asymptomatic infections we examined all during reoperations removed implant microbiologically.Between january 2009 and june 2010, 81 reoperations of an unknown synthes vertical expandable prosthetic titanium rib (veptr)-implants were performed.All lengthening operation retrieved implants were sonicated and the fluid used for microbiological work up.The following complications were reported: 9 of the probes showed bacteria growth, in 3 after enrichment, in 2 with a low germ count.Propionibacterium acnes was found in 3, coagulase negative staphylococcus in 5, staphylococcus epidermis and streptococcus in 1.1 child, an infection was suspected preoperative and confirmed microbiology.1 patient had histiocytosis.This is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 1 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8732667
• MDR Text Key: 149469112
• Report Number: 8030965-2019-65721
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention