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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/26/2019

Event Type  Injury  

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 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.

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.

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)
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8803282
• MDR Text Key: 151460015
• Report Number: 2027467-2019-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00844856091764
• UDI-Public: (01)00844856091764
• Combination Product (y/n): N
• PMA/PMN Number: K143149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR