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

Catalog Number	75446550
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: pre-revision and post revision x-rays for thoraco lumbar stabilization construct provided.In two of the provided images, there appears to be broken screw at the inferior level of a construct around a burst fracture.Each of the screws is connected probably 2 degree to osteoporosis.The construct was revised to a compacting graft at the fracture level.Hardware failure was likely 2 degree to failure of fusion given osteoporosis.Product analysis: visual, microscopic and dimensional evaluation confirmed the bone screw disassembled from the head.The ring and crown were still assembled in the head.A portion of the ring has been sheared through the cross-sectional area, with the remaining portion of the ring still seated in the groove of the head.The retaining ring is fully seated but has been deformed and partially sheared off.The deformed and sheared areas are on either side of the retaining ring gap and would reduce the force required for head disassembly.The diameter of the bone screw head in the undamaged area was checked and meets print spec.The above observations are consistent with overload as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent minimally invasive transforaminal lumbar interbody fusion.Post-op, the screw head and thread was found separated and broken.The product came in contact with patient.No fragments of the broken part remains in the patient.Patient complications were unknown.

• Brand Name: CD HORIZON
• 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: 8140015
• Report Number: 1030489-2018-01608
• Device Sequence Number: 18886258
• Product Code: KWP
• UDI-Device Identifier: 00885074134130
• UDI-Public: 00885074134130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 75446550
• Device Lot Number: H5359336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1