MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7570900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Pre-op diagnosis: nerve compression, leg pain procedure: rod inserted during spondylodesis.The inserter was 'beenachtig' the skin and fascia.Levels implanted: l3-l4 it was reported that intra-op, the tip of the rod inserter was reported broken.The two pins off the inner sleeve from the inserter were fixed into the tulip of the screw.When the doctor tried to loose the inserter from the rod the tip broke off.One of the two pins got out of the patient, the other one was stuck between the rod and the screw.The doctor accepted this instead of opening the skin and fascia.The product came in contact with the patient.There were fragments of the instrument remaining in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Additional information: product analysis: the rod inserter was returned with both of the tips on the inner shaft broke off.Only one of the tips was returned for analysis.Upon a microscopic review of the fracture surface, it appears the failure occurred as a result of the inserter handle being moved in an upward direction creating a bending moment.The fracture surface has a slight u shape to it also this is likely the result of the tip flexing over time to accommodate being locked on to and removed from the rod.While the final failure was a bending moment it appears that wear also plays a factor in the failure.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.
Event or Problem Description
No additional surgery scheduled to remove the fragments of the broken inserter from inside the patient.Patient is doing well.There are no complaints after 3 weeks.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6943511
• Report Number: 1030489-2017-02176
• Device Sequence Number: 682779
• Product Code: KWP
• UDI-Device Identifier: 00613994302748
• UDI-Public: 00613994302748
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K052747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2018

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: 7570900
• Device Lot Number: RS11H024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/24/2017; 12/13/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/20/2017; 01/09/2018
• 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: Other
• Patient Weight: 70