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

Catalog Number 54750015540

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2019

Event Type  Injury  

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 Description

Post op, the patient had to underwent revision surgery because the pedicle screw on the right of l1 which was on the most cranial side backed out due to loosening.During revision the surgeon cut the rod between l1/2 and removed only the pedicle screw on the right of l1.The backed out pedicle screw protrudes to the skin, and it was suspected that infection occurred there.The nearby soft tissue was collected and cultured.

Manufacturer Narrative

Additional information: post-op x-ray for anterior posterior fixation of l3 osteoporotic fracture provided.The posterior hardware appears undersized and there is a lucency/back out of l1 screw.The bone quality appears poor.No other hardware failure is identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9254391
• MDR Text Key: 164593494
• Report Number: 1030489-2019-01224
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169501249
• UDI-Public: 00643169501249
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: 54750015540
• Device Lot Number: H5237047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR