MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TAS; 12 DEG LORDOTIC, IMPLANT, LARGE, 17MM

Model Number 2312-0217

Device Problem Malposition of Device (2616)

Patient Problems Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Endoskeleton tas 12 deg lordotic, implant, large, 17 mm (p/n: 2312-0216, lot: a120246) was implanted with two tas 5.5 mm dia, standard, bone screws 30 mm (p/n: 2300-5530, lot: v13 and v01) and one tas 6.5 mm dia, standard bone screw, 25 mm (p/n: 2300-6525, lot: v03) on (b)(6) 2016.The devices were discarded by the hospital's sterile processing.Further investigation on the devices could not be performed.A review of the products' device history record was performed for the subject devices.The review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would contribute to this complaint condition.The devices passed inspection and were approved for initial use.Titan spine requested for images (ct or fluoroscopy) from the surgery.These have yet to be received by titan spine for investigation to be performed.Thus, the root cause of this complaint condition could not be determined at this time.If images are received, a follow up report will be completed with the investigation results.Device not returned.

Event Description

A l5-s1 alif procedure was completed on (b)(6) 2016.Screw extended beyond posterior border of implant once seated and impinged the nerve.The implant was removed and replaced on (b)(6) 2017.Patient has bladder related issues due to nerve damage.Patient has foot drop due to nerve damage.

• Brand Name: ENDOSKELETON® TAS
• Type of Device: 12 DEG LORDOTIC, IMPLANT, LARGE, 17MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• Manufacturer Contact: jeff groskopf ; 6140 w. executive dr. ste a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 6443710
• MDR Text Key: 71177321
• Report Number: 3006340236-2017-00004
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: M682231202170
• UDI-Public: +M682231202170/$A120246/16D20120201B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 2312-0217
• Device Catalogue Number: 2312-0217
• Device Lot Number: A120246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability