MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; MESH,SURGICAL

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.510k: this report is for an "unknwon" matrix neuro mesh /unknown lot.Part and lot numbers are unknown; udi number is unknown.Hardware was removed on an unknown date.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the patient was experiencing infection after the implantation of an unknown matrix recon mesh set and unknown matrix neuro as mentioned by the nurse.The mentioned implants were removed in another surgery.According to the charge nurse from the neuro and sterilization personnel that passed the cleaning and sterilization of the set, there was no notice of the case as well.Thus, the infection could happen of any number of reasons and that the sterilization of the set is their responsibility and not the company's.The surgeon explained that there were two (2) infections in the usage of the implants but no confirmation if it is the same bacteria or if it has something to do with the matrix neuro set.It was unknown if the patient reported underwent removal of same implants or each of the mentioned implants.This complaint involves (2) devices.This report is 2 of 2 for (b)(4).

• Type of Device: MESH,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8028498
• MDR Text Key: 125795308
• Report Number: 8030965-2018-57811
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• 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: 10/15/2018
• 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