MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	3603514
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient having posterior cervical fusion due to cervical myelopathy.It was reported that screw not tapping when inserted into pre-drilled hole.There were no symptoms reported.The product was replaced and will be returned.No further complications were reported.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10654894
• Report Number: 1030489-2020-01406
• Device Sequence Number: 3219922
• Product Code: KWP
• UDI-Device Identifier: 00643169554405
• UDI-Public: 00643169554405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 3603514
• Device Catalogue Number: 3603514
• Device Lot Number: H5605631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1