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

Catalog Number	55840016550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that intra-op, when the surgeon wanted to go deeper into the pedicle with the implant, the screw head of the implant came loose from the rest of the screw.The product came in contact with the patient.The product broke.No fragment of the implant remaining in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: just the head returned.There are witness marks on the bottom of the head were it appears that the head came in contract with another object.There is deformation on the ring of the mas where the bone screw pushed through.There is damage to the inside portion of the saddle that the cause of is unknown.They bone screw would have allowed for a more through analysis of the root cause.With the information gained from the part received it would appear the retaining ring was overloaded.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: 7141539
• Report Number: 1030489-2017-02548
• Device Sequence Number: 1014368
• Product Code: KWP
• UDI-Device Identifier: 00643169077294
• UDI-Public: 00643169077294
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113174
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 55840016550
• Device Lot Number: H5369171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR