MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

It was reported that plate # 55-15505 was being used in a procedure, and as the 4th screw was being inserted, the head broke off from the screw.The initial plate was left in place.The surgeon felt the need for additional reinforcement due to the lack of the fourth screw in the initial plate, so a second plate was put in to secure the area.There were no adverse consequences reported.

Manufacturer Narrative

Device not returned for evaluation as it still implanted in the patient.If additional information is received it will be reported on a supplemental report.Device implanted in patient.

• Brand Name: UNKNOWN_FRO_PRODUCT
• 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: 4331339
• MDR Text Key: 5143469
• Report Number: 0008010177-2014-00349
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/16/2014
• 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