MAUDE Adverse Event Report: ALPHATEC SPINE INC CORTICO-CANCELLOUS SCREW 5.5 MM X 35 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47400-055-035
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been returned for evaluation nor has the manufacturing lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
The patient complained of having pain and went in for an appointment.After x-rays the surgeon discovered screw was broken.Revision surgery scheduled for (b)(6) 2019.The arsenal fixation system was originally implanted on (b)(6) 2019.
Additional Manufacturer Narrative
Model & catalog# initially reported as 47400-055-035, corrected data: 47410-055-035.The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Upon investigation of the screw assembly pn 47410-055-035 and the shank component pn 47400-3-55-035, it is noted that the screw shank has a material transition from the neck to the minor diameter within the proximal cancellous threads.This transition to the minor occurs at a distance "e", which per the print is 6mm from the base of the neck.Upon visual investigation, it is noted that the location of fracture is approx.At the same distance.Therefore, the failure is attributed to shear of the shank at or close to the minor diameter.

• Brand Name: CORTICO-CANCELLOUS SCREW 5.5 MM X 35 MM (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8803282
• Report Number: 2027467-2019-00034
• Device Sequence Number: 327145
• Product Code: NKB
• UDI-Device Identifier: 00844856091764
• UDI-Public: (01)00844856091764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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: 47400-055-035
• Device Catalogue Number: 47400-055-035
• Device Lot Number: SM95319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 06/19/2019; 06/19/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/15/2019
• 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: Hospitalization
• Patient Age: 53 YR