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

Catalog Number 75646535

Device Problems Corroded (1131); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product analysis: microscopic and sem examination of the set screws revealed severe pitting present on the set screw where they interface with the mas threads, as well as at the base of the set screw where it interfaces with the rod.This severe pitting could mechanically weaken the attachment points of the construct.Both the mas head and the set screw are made from astm f2229 stainless steel.Microscopic examination of the mas revealed pitting present at the base of the saddle/u-channel where it interfaces with the rod, as well as in the set screw interface threads.The pitted locations are around component interface points.The pitted areas seen under microscopic and sem examination appear to have a striated granular appearance with cubical voids, when viewed under very high magnification.These voids are indicative of chemical attack.The pitting seen at these construct interface points, when as sembled, provide crevices which can promote in vivo corrosion.Only the set screws were examined via sem (scanning electron microscope), due to sem chamber size constraints.Sem microscopy identified cuboidal pitting /voids seen on set screw rod interface surfaces.Complaint returned product corrosion location and surface morphology consistent with crevice corrosion.Microscopic examination of mas head identified crystallographic pitting in the rod saddle / mas head, consistent in location and surface morphology with crevice corrosion.Stainless steel corrosion resistance is obtained from a passive film which forms in an oxygen rich environment; the presence of large amounts of biological material may have generated oxygen deficient regions, resulting anodic cell development, which would result in the loss of the passive film and eventual corrosion of the material.Additionally, micro-motion of the components may have also contributed by mechanically removing the passive film formed on the stainless steel.No other material signs of wear, cracking, fracture or breakage were identified.The location pitted surface morphology and microstructures are consistent with anticipated wear due to crevice corrosion.

Event Description

It was reported that the patient underwent a surgery due to scoliosis at t2-l2.Post-op, the patient had bent over and felt a "pop" in her back.X-rays noticed that the pedicle screw was pulling out.Revision surgery was done to remove, re-instrument and add additional levels.The implant did not break but corrosion was seen in the implant.The patient did not achieve solid fusion.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5995939
• MDR Text Key: 56332911
• Report Number: 1030489-2016-02743
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75646535
• Device Lot Number: H13C3207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROD
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR