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

Catalog Number	5540130
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.However, product images were submitted.Submitted images appear to display witness marks on set screw threads.
Event or Problem Description
It was reported that patient with pre operative diagnosis of spondylolisthesis at l4/5 underwent transforaminal lumbar interbody fus ion at l4 and l5.Intra-op, during reduction of spondylolisthesis,the left l4 reduction multi axial screw stripped the set screw.Products came in contact with the patient.Stripped pieces of the implant was washed out with water.
Additional Manufacturer Narrative
Product analysis: a microscopic review of the set screw revealed that there is what appears to be some pealing on the - 5-degree flank.This has been seen before and can be the result of the edges of the bone screw not being broken during the blasting process.This sharp edge can cause the flank of the bone peal away.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: 6806669
• Report Number: 1030489-2017-01932
• Device Sequence Number: 16177780
• Product Code: KWP
• UDI-Device Identifier: 00643169007987
• UDI-Public: 00643169007987
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 5540130
• Device Lot Number: H5330695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR