FDA Adverse Event Injury Summary report: N

CD HORIZON® SOLERA® SPINAL SYSTEM

MDR report key: 14070438 · Received April 11, 2022

Report

Report Number: 1030489-2022-00334
Event Type: Injury
Date Received: April 11, 2022
Date of Event: March 16, 2022
Report Date: April 11, 2022
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: NKB
PMA / PMN Number: K170679
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T9-L5 PPS/L2 BKP. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS OVF. IT WAS REPORTED THAT THE RIGHT L5 ROD CAME OFF FROM THE SCREW, SO REINSTALLATION WAS PERFORMED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATED INFORMATION REPORTED ON (B)(6) 2022: THE ROD CAME OFF. THE SET SCREW WAS TIGHTENED. THE ATTENDING PHYSICIAN COMMENTED THAT THE ROD MIGHT HAVE BEEN SHORT. BOTH THE ROD AND THE SET SCREW WERE REPLACED DURING REPEAT SURGERY. THE REMOVED ROD AND SET SCREW ARE DISPOSED OF IN THE HOSPITAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2443816	CD HORIZON® SOLERA® SPINAL SYSTEM	THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM	NKB	MDT SOFAMOR DANEK PUERTO RICO MFG	6534530	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Required Intervention