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

Catalog Number 54850017550

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Type  Injury  

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 Description

It was reported that the patient underwent an unknown surgery with multi axial screw (mas) screw.Reportedly, postoperatively, the screw head popped off the bone screw, as a result the patient developed pain.Patient underwent revision surgery for explant of the screw.No fragments of the implant remained inside the patient.No patient complications were reported after the revision surgery.

Manufacturer Narrative

Post-op x-rays for l5-s1 tlif show a fracture of the tulip from the screw at six months post-op.A spondylolisthesis still exists at l5-s1 and fusion has not occured.This hardware failure may be a result of failure of fusion with a persistent mobile deformity.The hardware 4.75 screw is probably also undersized for the level/patient size.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA 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: 7074239
• MDR Text Key: 93431358
• Report Number: 1030489-2017-02411
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169491632
• UDI-Public: 00643169491632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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 Catalogue Number: 54850017550
• Device Lot Number: H5162949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2015
• 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: 46 YR
• Patient Weight: 97