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

Catalog Number 54740006545

Device Problem Break (1069)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device, catalog # 54840006545, 510k #k091974 and udi # (b)(4) was cleared in the united states.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 transforaminal lumbar interbody fusion at l5-s1 and posterior fixation at l4-iliac.On an unknown date, post-op, the screw on the left side of l5 broke and stenosis was observed.Bone-union was achieved.It was planned to replace the broken screw and extend fusion during the revision surgery.On (b)(6) 2019, a revision surgery was performed.The broken part of the screw was very difficult to remove; hence, it was left implanted as it was.Other screws were successfully removed.Fixation was also performed at l4-iliac during this revision surgery.

Manufacturer Narrative

Product analysis: visual and microscopic inspection confirmed the mas was returned with the bone screw broken about 10 threads down from the head of the screw.The broken portion of the screw was not returned.The damage would appear to be the result of the removal process.There are beach marks running through the fracture surface indicating cyclic fatigue.When reviewing the saddle of the mas it is noted that the rod does not appear to have been seated evenly in the saddle, which could place extra stress on the screw.The screw will no longer pivot on the crown of the screw.This type of damage is consistent with cyclic fatigue followed by overload.X-ray review results: intra-op imaging from lumbar fusion revision surgery provided.It is unclear which level is shown in images.Description of event says screw broke at l5.There is a screw fragment in the l5 vertebral body.Interbody spacers are present at the levels above and below.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON 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: 8701273
• MDR Text Key: 148069818
• Report Number: 1030489-2019-00625
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: 54740006545
• Device Lot Number: H11A5470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2010
• 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): Required Intervention