MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW

Model Number 25-660-04-91

Device Problems Migration or Expulsion of Device (1395); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00060 and mdr 9610905-2018-00061.

Event Description

It was reported that screws were found no longer fixated in mandibular bone during the consolidation period of a distraction case.The product was removed.Doctor felt adequate consolidation had occurred post-distraction and no additional fixation methods were used.

Manufacturer Narrative

The stereo microscope investigation revealed surface damage but no cracks.Further observation determined there were no indications of material or manufacturing defects.The review of the device history records was not possible due to no lot number being identified or provided.The root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Type of Device: SCREW
• 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: 7506056
• MDR Text Key: 107962592
• Report Number: 9610905-2018-00059
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118042743
• UDI-Public: (01)00888118042743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944561
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-660-04-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 2 MO
• Patient Weight: 4