MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® CORTICAL SCREW 4.5; LOQTEQ® CORTICAL SCREW 4.5, S. HEAD, T25

Model Number	SK 4526-XX-2
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A breakage of a cortical screw 4.5 occured during a hto-plate explantation.The implant was completely removed.
Event or Problem Description
Breakage of a cortical screw d4.5 occured during explantation of a hto-plate.

• Brand Name: LOQTEQ® CORTICAL SCREW 4.5
• Common Device Name: LOQTEQ® CORTICAL SCREW 4.5, S. HEAD, T25
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• MDR Report Key: 6639452
• Report Number: 8043862-2017-00004
• Device Sequence Number: 11033392
• Product Code: HWC
• UDI-Device Identifier: 04042409213946
• UDI-Public: 04042409213946
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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
• Operator of Device: Health Professional
• Device Model Number: SK 4526-XX-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1