MAUDE Adverse Event Report: ALPHATEC SPINE INC PRE-CONTOURED / C.P. TI ROD 5.5 MM X 5 CM (CP TITANIUM - GRADE IV); PEDICLE SCREW SYSTEM

Model Number	73600-050
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.The illico mis posterior fixation system is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.When used for a minimally invasive posterior approach illico mis instrumentation is used in conjunction with polyaxial screw components.The implants are manufactured from surgical grade titanium alloy (ti-6al-4v eli or ti-6al-4v).The rods are available in commercially pure (cp) titanium and/or cobalt chrome.
Event or Problem Description
On (b)(6) 2019 a patient returned to the surgeon's office complaining of recent increased pain.X-rays taken that day revealed a fractured illico rod.Revision surgery will be conducted but has not yet been scheduled.The illico posterior fixation system was originally implanted on (b)(6) 2018.

• Brand Name: PRE-CONTOURED / C.P. TI ROD 5.5 MM X 5 CM (CP TITANIUM - GRADE IV)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8586783
• Report Number: 2027467-2019-00024
• Device Sequence Number: 2191800
• Product Code: NKB
• UDI-Device Identifier: 00844856043510
• UDI-Public: (01)00844856043510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 73600-050
• Device Catalogue Number: 73600-050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/07/2019
• 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: Other
• Patient Age: 52 YR