MAUDE Adverse Event Report: CORELINK, LLC ANODYNE ANTERIOR CERVICAL PLATE SYSTEM; SPINAL FIXATION DEVICE

Model Number	20445-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.Device left in patient at this time per the complainant.No lot number was provided by the user, however two lots of this part were available to the user at time of use.These two lots dhrs were reviewed with inconclusive results.Device not returned.
Event or Problem Description
Customer alleges that a patient who had a 2 level acdf (c4-c6) had an early screw fracture.The original implantation date was (b)(6) 2017 and corelink was notified of the alleged fracture on (b)(6) 2017.The fracture was discovered during the patients post-surgery follow-up.The user identifies the patient to be a "larger woman", (b)(6) (no exact weight or date of birth was provided).The alleged screw fracture took place at the c6 level.The screw utilized was a 4.5mm x 18mm fixed angle self tapping screw (20445-18) used in conjunction with 5 other screws and a 30mm 2 level plate.

• Brand Name: ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL FIXATION DEVICE
• Manufacturer (Section D): CORELINK, LLC; 7911 forsyth blvd; suite 200; saint louis MO 63105
• MDR Report Key: 6695371
• Report Number: 3006494201-2017-00011
• Device Sequence Number: 13661080
• Product Code: KWQ
• UDI-Device Identifier: M7252044518
• UDI-Public: M7252044518
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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: Physician
• Device Model Number: 20445-18
• Device Catalogue Number: 20445-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR