MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number MSB_UNK_SOL5.5/6.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/30/2020

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

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of proximal junctional kyphosis of l1.It was reported that the tip of driver broke when the rod-side set screw of the reported connector placed on lamina at l1 was removed and it remained in the set screw.Therefore, the product was removed together with rod.Two transelace had been used and it was able to remove the other one without any problems.The tensioner was not used at the time of removal.The initial operation is done on (b)(6) 2018.Fusion was performed with solera56 on l2/5.Transelace was placed on l1.After the operation, pjk on l1 occurred which leads to the operation this time.One of solera was implanted in the first surgery(unknown date) and related complaint is revision surgery due to proximal junctional kyphosis and for other solera implanted in the surgery on (b)(6) 2018 ,related complaint is replacement surgery due to unknown reason.In the operation on (b)(6) 2020, all solera56 were removed and replaced with voyager56, fusion on th10/illiac was performed.The event of the reported connector being unable to be removed at the time of removal occurred.Solera5.5 is replaced with voyager5.5 as it is single use and there is simplicity of rod connection.There was no malfunction on solera56 product itself.No health damage in the patient was reported.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 10717113
• MDR Text Key: 212455578
• Report Number: 1030489-2020-01465
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SOL5.5/6.0
• Device Catalogue Number: MSB_UNK_SOL5.5/6.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• 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