MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	54840006540
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
Product was not 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 the patient underwent spinal fusion at l5-s1 in 2015.Post-op, the screw broke.A revision surgery was performed to remove the broken screws at s1, refusion at l5-s1 and fixation l4-5 ,s1-2.Fragments of the broken product remained inside the patient.Patient complication reported to be unknown.
Additional Manufacturer Narrative
Only year is valid.Date and month of implant are not confirmed.X-ray review results: intra-op films for l5-s1 posterior fusion revision surgery shows two broken screws in the sacrum.Original implant date is 2015.There is no bone or interbody spacer at l5-s1.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8256261
• Report Number: 1030489-2019-00069
• Device Sequence Number: 1960128
• Product Code: NKB
• UDI-Device Identifier: 00613994579621
• UDI-Public: 00613994579621
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2019

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: 54840006540
• Device Lot Number: H11C4946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/27/2019
• 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: 27 YR