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

Catalog Number	54410006550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
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
It was reported that the patient underwent spine surgery.Intra-op, while the plugs were being locked to secure the titanium rod on the mono-axial screw, the screw broke.The broken implant was completely removed.A new implant was used along with the new locking plugs.There was a delay in overall procedure.Patient complications were reported to be unknown.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection revealed the head of the screw had been damaged.Part of the screw head has been broken off with only one row of threads remaining on that side.Optical inspection did not reveal and cracks or damage that could contribute to the screw breaking.It appears the head of the screw was overloaded during the rod and set screw tightening process.This type of damage is consistent with bend stress overload.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: 8834088
• Report Number: 1030489-2019-00826
• Device Sequence Number: 2070855
• Product Code: NKB
• UDI-Device Identifier: 00613994585721
• UDI-Public: 00613994585721
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 54410006550
• Device Lot Number: H11F3684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1