MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ILLICO; LXH

Model Number	73770-20-2
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Guide wire broken during the surgery.(b)(6) 2021: description of the surgery (l4/5tlif, l5/6plif, l4/5/6plf).It was found that the wire was bent when removing the wire during the install of the screw.Measuring the length of the wire when replacing it with the normal item, it proved that the concerned wire was shorter by 5-10mm.It was also found that the broken tip part remained in the patient's body when checking the concerned level by the image.The tip part could not be removed, therefore remained in with the surgeon decision.Then the surgery was completed.Revision surgery is not scheduled.
Additional Manufacturer Narrative
Corrected data: d9: yes.Additional information: h3: yes.H6: medical device problem: 1260.Medical device component: 463.Type of investigation: 10.Investigation findings: 4248.Investigation conclusion: 61.H10: the device returned and visual inspection was conducted on 10/13/2021 which confirmed the event.A portion of the tip appears to have sheared off.No patient injury was reported.The fragment, which was reported to be irretrievable, is manufactured out of nitinol, a shape memory alloy constructed out of a combination of nickel and titanium.The nitinol used in the manufacturing of guidewires is processed and certified according to astm f2063 specifications.The lot number was not identified; therefore, device history records could not be reviewed.The root cause is likely a result of nitinol exhibits enormous elasticity and is the material of choice for applications requiring enormous flexibility and motion it is believed the guidewire encountered excessive stress/fatigue by redirecting the original path upon inserting the screw.

• Brand Name: ILLICO
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12021309
• Report Number: 2027467-2021-00037
• Device Sequence Number: 19810886
• Product Code: LXH
• UDI-Device Identifier: 00844856057654
• UDI-Public: 00844856057654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 73770-20-2
• Device Catalogue Number: 73770-20-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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