MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BASIC ORBITAL FLOOR PLATE, MEDIUM,STERILE, 0.3MM; IMPLANT

Catalog Number 10-03002

Device Problem Device Inoperable (1663)

Patient Problem Pain (1994)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

An orbital plate was used in surgery for an orbital floor fracture.Before the surgery, the plate was cut in half longitudinally because it was too wide for the patient.After the surgery, the patient presented with eye pain and the plate and screws were extracted on the same day.

Manufacturer Narrative

Device not returned for evaluation as the patient retained the device.If additional information is received, it will be reported on a supplemental report.Device retained by patient.

• Brand Name: BASIC ORBITAL FLOOR PLATE, MEDIUM,STERILE, 0.3MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: julie schoell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3953604
• MDR Text Key: 20972881
• Report Number: 0008010177-2014-00188
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10-03002
• Device Lot Number: M4T01FAV06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/23/2014
• 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