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

Model Number	55850016550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- painful orth opedic hardware after procedure involved in minimally invasive techniques for transforaminal lumbar interbody fusion (mis tlif).Levels implanted- l5-s1.It was reported that during use, the patient heard a pop in their back.Reported the breakage was due to the weight of the patient.Product was utilized correctly according to the directions given in the ifu/labeling.Revision surgery was performed to explant the product, as patient had increase back pain because of the broken screw.There were no broken fragments left in the patient body.There was no delay in overall procedure time.After revision surgery, patient is recovering.Patient is alive and no injury.

• Brand Name: CD HORIZON SOLERA VOYAGER 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: 11553695
• Report Number: 1030489-2021-00392
• Device Sequence Number: 14410011
• Product Code: NKB
• UDI-Device Identifier: 00643169768284
• UDI-Public: 00643169768284
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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 Model Number: 55850016550
• Device Catalogue Number: 55850016550
• Device Lot Number: H5544144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/23/2021
• 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: 186