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

Catalog Number	55840009580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Levels implanted: t2-iliac crest pre-op diagnosis.Broken screw and rods procedure: remove broken screw (tulip head only) and replace broken rods it was reported that on an unknown date, post-op, the patient underwent a surgery for removal of a broken screw.The screw was removed partially.
Additional Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture near the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Optical examination of the fracture surface noted significant fracture surface damage and smearing.Microscopic examination of the undamaged portions of the fracture surface identified a fairly flat fracture surface and gently curving convex striations through the cross-sectional area of the implant, which are indicative of cyclic fatigue until subsequent mechanical failure of the implant.After visual and microscopic examination, no evidence was found that would suggest a defect in manufacturing or processing of the implant components.The above observations are consistent with cyclic fatigue.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: 6577663
• Report Number: 1030489-2017-01267
• Device Sequence Number: 11020984
• Product Code: KWP
• UDI-Device Identifier: 00643169005341
• UDI-Public: 00643169005341
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55840009580
• Device Lot Number: H5231975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 09/15/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 09/19/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention