MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-07550

Device Problems Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  malfunction  

Event Description

A company representative reported that the shaft diameter of a mesa polyaxial screw was measured and found to be a different size than what was listed on the head of the screw.Review of product manufacturing history indicates this is an isolated incident.

Manufacturer Narrative

Visual and dimensional inspection was performed and the screw measured at ø6.55 x 50 mm, compared to the laser marked diameter of ø7.5 x 50 mm. lot hhjr was released in a size of 85 units and inspected september 2018.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.  complaint history was reviewed and no similar complaints were identified for this lot.  the non-conformance and corrective preventive action investigation performed with the supplier has concluded that this is an isolated occurrence and that the discrepancy was limited to the one screw, described in this report.During the time period when the 7.5 x 50 mm screw lots were in inventory, 6.5 x 50 mm screws were received into inventory.Records show 1 piece from production lot of 6.5 x 50 mm screws was missing.It was concluded that the qc inspector was not using the gage in a "no-go" condition, which may have allowed a smaller shaft diameter to pass the gage.

Event Description

A company representative reported that the shaft diameter of a mesa polyaxial screw was measured and found to be a different size than what was listed on the head of the screw.

• Brand Name: POLYAXIAL SCREW; SIZE 7.5X50 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10378471
• MDR Text Key: 202015726
• Report Number: 3004774118-2020-00166
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857136885
• UDI-Public: 10888857136885
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 801-07550
• Device Catalogue Number: 801-07550
• Device Lot Number: HHJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1