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

Catalog Number	7896545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
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
Type of procedure: lumbar fusion levels.Implanted: l2-s1.Product status: partially explanted.It was reported that on an unknown date, post-op, the screws at s1 broke due to which there was non-fusion at l5-s1.The patient also reported back pain due to this event.All the other levels of the operated spine had fused.On (b)(6) 2018, a revision was performed wherein the broken screws were partially explanted.The broken pieces of screw remained in s1 and could not be explanted.The screws broke 8-10mm below the surface of the bone.Trephines and conical extraction bolts were ready, but the surgeon thought it would be safer and less invasive to place the two new screws next to the broken screws is a safe area of s1.The two new screws were placed in a safe area and were well fixed.A second imaging was performed to confirm proper placement of the two new screws.No complications were reported after the revision surgery.
Additional Manufacturer Narrative
Product analysis: the shaft of the bone screw has broken approximately 4 threads from the head of the screw.Microscopic examination of the fracture surface identified a fairly flat fracture surface for approximately 50% of the cross section with multiple ratchet marks near the area of crack propagation, followed by gently convex progressive striations, consistent with cyclic fatigue.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: 8154311
• Report Number: 1030489-2018-01642
• Device Sequence Number: 18893140
• Product Code: KWP
• UDI-Device Identifier: 00613994291509
• UDI-Public: 00613994291509
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 7896545
• Device Lot Number: H5080617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: 59 YR
• Patient Weight: 76