MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	55840007560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2016
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.Image review: submitted images appear to display mas separated from the bone screw, and two driver tips sheared off at the distal tip.
Event or Problem Description
It was reported during surgery, the pedicle screw broke when the surgeon tried to remove it.The product came in contact with patient.Fragments of the broken screw remained in patient.Patient complications are unknown.
Additional Manufacturer Narrative
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.
Event or Problem Description
Procedure: spondylodesis posterolateralis l5-s1, decompression at l5/s1 cum laminectomy no patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual inspection confirms only the head assembly of the implant returned for analysis, with the (-01) bone screw component missing and not returned for analysis.The ring (-04) and crown (-03) were still assembled in the head.Microscopic examination of the (-04) ring identified ring id feature material displacement, enlarging the id, and the "ears" of the ring bent upward, thus reducing the mechanical retention of the bone screw head.The ring is noted to be fully seated in the retaining groove of the head.The above observations are consistent with mechanical overload as the mechanism of failure.
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: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6212075
• Report Number: 1030489-2016-03602
• Device Sequence Number: 141695
• Product Code: NKB
• UDI-Device Identifier: 00643169004375
• UDI-Public: 00643169004375
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K113174
• 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,Followup
• Report Date (Section B): 03/02/2017

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: 55840007560
• Device Lot Number: H5156171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/02/2017
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 02/20/2017; 03/03/2017; 09/29/2017
• 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: 89