MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75445540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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 the patient underwent posterior instrumentation for scoliosis.Intra-operative, screw head was broken while tightening of nut.The product came in contact with patient.No fragments of the broken screw remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Visual inspection confirms the bone screw disassembled from the mas head.The ring and crown are still assembled in the head.Microscopic examination of the mas assembly identified a portion of the retaining ring is fully seated, but has been sheared through the cross sectional area on both sides of the retaining ring gap, thus allowing disassembly.The remaining portion of the retaining ring is still seated in the groove of the head.Dimensional inspection of the bone screw head diameter found to be within print specification.After completed analysis, no evidence was found that would suggest a defect in design or manufacturing of the implant.The above observations are consistent with overload as the mechanism of failure.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: 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: 6656167
• Report Number: 1030489-2017-01605
• Device Sequence Number: 1149698
• Product Code: KWP
• UDI-Device Identifier: 00885074134017
• UDI-Public: 00885074134017
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2017

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 Catalogue Number: 75445540
• Device Lot Number: H5307700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 07/13/2017; 07/13/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/09/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 50