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

Catalog Number	55840006545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's year of birth is (b)(6) (year valid).Explant date is unknown but it happened in (b)(6) 2017.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that the patient underwent fusion surgery at l4-s1.Reportedly, post-op, the patient had a superficial wound infection that healed well after antibiotic treatment.Since (b)(6) 2017, the patient had gained pain in the back and noted a sparkling noise in her back.A ct was conducted in (b)(6) 2017, which showed that the screws were fine.A supplementary provocation ct in (b)(6) 2017, however, showed broken screw.The patient underwent revision surgery for removal of broken screw and rest of the construct as well.Everything was replaced with new implants in the surgery.The patient had not achieved solid fusion.The tips from the two broken s1-screws couldn't be removed and were left in the body as the surgeons didn't want to cause more tissue trauma and risk infection.
Additional Manufacturer Narrative
Additional information: image review: submitted images appear to display broken mas screws at the right and left s1 pedicles.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at approximately 3 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross-sectional area of the implant, which is indicative of cyclic fatigue until subsequent mechanical failure of the implant.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: 6844238
• Report Number: 1030489-2017-02000
• Device Sequence Number: 1430187
• Product Code: KWP
• UDI-Device Identifier: 00613994971753
• UDI-Public: 00613994971753
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: 55840006545
• Device Lot Number: H5341852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 11/13/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/29/2017; 12/07/2017
• 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 Weight: 67