MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® CORTICAL SCREW 4.5; LOQTEQ® CORTICAL SCREW 4.5, S. HEAD, T25, L70

Model Number	SK 4526-70-2
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A breakage of a cortical screw 4.5 occured or was detected during a planed removal of a hto-plate.A piece of the screw remained in situ.
Event or Problem Description
Breakage of a cortical screw d4.5 occured or was discovered during explantation of a hto-plate at (b)(6) hospital.

• Brand Name: LOQTEQ® CORTICAL SCREW 4.5
• Common Device Name: LOQTEQ® CORTICAL SCREW 4.5, S. HEAD, T25, L70
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• MDR Report Key: 6639451
• Report Number: 8043862-2017-00003
• Device Sequence Number: 555357
• Product Code: HWC
• UDI-Device Identifier: 04042409213946
• UDI-Public: 04042409213946
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• 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 4526-70-2
• Device Lot Number: K061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• 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
• Patient Age: 51 YR
• Patient Weight: 91