MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; TEMPLATE

Catalog Number	5484321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that on (b)(6) 2016, intra-op, spacer broke.Spacer did not break into pieces.Reportedly, doctor wanted to insert a hook with the rods because of limit space of the pedicle.When the doctor inserted everything, he realized that there were no thread inside of the hook to tighten the construction, and had to remove everything to replace the hook.Product came in contact with the patient.No fragment of the implant remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: associated part is a trial (instrument), thus it is not intended as an implant, and does not require a thread.Instrument visually undamaged and appears to be capable of performing its intended function.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6153793
• Report Number: 1030489-2016-03359
• Device Sequence Number: 861257
• Product Code: HWT
• UDI-Device Identifier: 00885074242057
• UDI-Public: 00885074242057
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2017

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 5484321
• Device Lot Number: 0176386W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided; 02/22/2017
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 03/20/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR