MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Please note, the exact quantity of screws that became loose is unknown.The article did indicate that three of these screws became lost due to the loosening.Device not available.Failure determined through article, not facility/customer.

Event Description

It was written in a journal article that in a study of strut versus miniplate for fractures of mandibular angle, one patient experienced a loosening of the champy plate which was implanted plus three missing screws.The plate itself was intact and bone healing had been achieved.He underwent hardware removal, and no additional fixation was necessary.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 7152762
• MDR Text Key: 95979727
• Report Number: 0008010177-2017-00319
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2017
• 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): Required Intervention