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

Catalog Number	75446545
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 applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was implanted with a screw.Post-op, the screw broke.The patient underwent revision surgery for removal of the screw.No fragments of the screw remained inside the patient.The patient had not achieved solid fusion.
Additional Manufacturer Narrative
Radiological image review result: single saggital ct slice shows broken screw at s1.No bony fusion could be seen by report.By report, screw fractured 4 months post implant.The hardware placement in the ct appears appropriate.Additional information: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual inspection confirms the bone screw has been disassembled from the head.The ring and crown were still assembled in the head.The retaining ring is fully seated, but the ends of the ring has been deformed and partially sheared/split with half of the ring still seated and part of it protruding out.It appears the retaining ring was overloaded upon the removal of the screw.The bone screw head was measured 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.
Additional Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure: extending existing spondylodesis from l4-s1 to l3-4-s1-iliac crest screws no patient complications have been reported after the revision surgery.

• 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: 7430502
• Report Number: 1030489-2018-00554
• Device Sequence Number: 1677425
• Product Code: KWP
• UDI-Device Identifier: 00885074134123
• UDI-Public: 00885074134123
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/21/2019

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: 75446545
• Device Lot Number: H5372929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 11/27/2018; 01/16/2019
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 10/05/2018; 11/30/2018; 01/21/2019
• 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: 60 YR
• Patient Weight: 92