MAUDE Adverse Event Report: SPINAL ELEMENTS, INC LUCENT; INTERVERTEBRAL FUSION DEVICE

Model Number	10010-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was evaluated and no deviations or discrepancies were observed.Returned device was evaluated and the complaint was confirmed.Device met specifications except in the area of damage which could not be measured.The distal prong of the inserter was fractured off.The fragment was not returned.No radiographs confirming the location of the device fragment was received.There was no patient injury reported with the event.The surgeon elected to leave the fragment in-situ.Labeling review notes: "intraoperative management breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel." "manual surgical instruments warnings.Care should be taken in handling such instruments to avoid injury to the user or patient." the root cause is unknown, but the fracture may be the result of excessive manipulation of the inserter device during implantation.
Event or Problem Description
During a transforaminal lumber interbody fusion (tlif) surgery, one of the distal prongs of the interbody inserter fractured while inserting the peek interbody cage.The peek cage was successfully placed but the inserter fragment remained.The surgeon elected to leave the fragment in-situ.No patient injury was reported.

• Brand Name: LUCENT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 9413699
• Report Number: 3004893332-2019-00011
• Device Sequence Number: 3999730
• Product Code: MAX
• UDI-Device Identifier: 00840606122061
• UDI-Public: 00840606122061
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K081968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10010-000
• Device Lot Number: 060198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR