MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG RXG MESH; BONE PLATE

Model Number 52-849-00-04

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Inflammation (1932); Tissue Breakdown (2681)

Event Date 10/18/2015

Event Type  Injury  

Manufacturer Narrative

This is one of three related mdrs.Please refer to mdr 9610905-2015-00059 & mdr 9610905-2015-00060.

Event Description

Three (3) months following implantation, the patient was taken back to the operating room due to inflammation and tissue breakdown around the surgical site.Upon re-opening, the doctor discovered the plate was not fixated and it was removed from the patient.No new plate was implanted due to the bone being successfully healed.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was sent back for evaluation.It is determined that the complaint percentage falls well within the product risk limits that are adhered to at klm.The material and device history records were also reviewed based on the lot number provided and revealed no abnormalities.Due to no physical device available for evaluation, the reported incident cannot be appropriately validated and the root cause cannot be determined.If further information can be gathered that can add value to the contents of the investigated report, an additional follow-up report wil be submitted.

• Brand Name: RXG MESH
• Type of Device: BONE PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 5218502
• MDR Text Key: 30986040
• Report Number: 9610905-2015-00058
• Device Sequence Number: 1
• Product Code: GWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 52-849-00-04
• Device Lot Number: 32796351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 MO