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

Model Number	50-340-08-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
While the doctor was placing the orthoanchor screw it snapped in half.Remaining shaft of the screw was left in the patient.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken distractors returned.The stereo microscope investigation revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The device history records could not be reviewed due to the lot number not being provided by the customer.The results of the investigation have concluded that the root cause for breakage was due to mechanical overload on the devices.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 ORTHOANCHOR
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6983050
• Report Number: 9610905-2017-00081
• Device Sequence Number: 488929
• Product Code: DZE
• UDI-Device Identifier: 00888118075390
• UDI-Public: (01)00888118075390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K033483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017
• Report Date (Section F): 09/27/2017

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
• Operator of Device: Physician
• Device Model Number: 50-340-08-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR