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

Model Number	2312-0217
Health Effect - Clinical Codes	Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 12 DEG LORDOTIC, IMPLANT, LARGE, 17MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6443710
• Report Number: 3006340236-2017-00004
• Device Sequence Number: 18846585
• Product Code: OVD
• UDI-Device Identifier: M682231202170
• UDI-Public: +M682231202170/$A120246/16D20120201B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 2312-0217
• Device Catalogue Number: 2312-0217
• Device Lot Number: A120246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability