MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7226540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on an unknown date, the patient underwent l4-s1 fusion and stabilization.On an unknown date, post-op, the implanted screw broke.Broken screws and rods were observed on patient's x-ray.Hence, on (b)(6) 2019, the patient underwent a revision surgery, in which the broken implants were explanted and were replaced by implants from another manufacturer.No fragment of the broken implants remained inside the patient.
Additional Manufacturer Narrative
Product analysis: visual examination revealed the screw was broken about 5 threads down from the base of the bone screw head.Optical examination of the area of fracture initiation did not identify a pre-existing surface defect that could contribute to crack propagation.Some fracture surface smearing is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with progressive striations consistent with cyclic fatigue.The threads of the broken lower portion of the screw have been damaged, possibly from the removal process.The above observations are consistent with cyclic fatigue followed by overload once the fatigue had weakened the material.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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8987520
• Report Number: 1030489-2019-01005
• Device Sequence Number: 19664022
• Product Code: KWP
• UDI-Device Identifier: 00885074362892
• UDI-Public: 00885074362892
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K182928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 7226540
• Device Lot Number: 0335858W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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
• Patient Age: 37 YR