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 6534530

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2020

Event Type  malfunction  

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

It was reported that the patient underwent olif(oblique lateral interbody fusion) at l3/4/5, tlif(transforaminal lumbar interbody fusion) at l5/s and pps(percutaneous pedicle screw placement) at l3-s due to spinal canal stenosis.Intra-op, the set screws of l3 and s which had been applied compression was loose after the final tightening.The set screws were not tightened after the final tightening.The set screws were tightened again with a t27 driver and the procedure was finished.There was a delay of less than 60 mins in overall procedure time.There were no patient symptoms or complications reported as a result of this event.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10231465
• MDR Text Key: 197591199
• Report Number: 1030489-2020-00817
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 20643169885831
• UDI-Public: 20643169885831
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170679
• 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
• Report Date: 07/06/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 6534530
• Device Lot Number: H5595311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1