MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE 4.0X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04018DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
Physician reported that 2 ozark view self-starting, variable screws; size ø4.0x18 mm fractured 1-3 months post-operatively.The device remains implanted and revision surgery has not been scheduled at this time.This report captures the first of the two screws.
Additional Manufacturer Narrative
B.1.: updated from 'product problem' to 'adverse event and product problem.' b.5.: updated to reflect revision surgery has occurred.H.1.: updated from 'malfunction' to 'serious injury.'.
Event or Problem Description
Physician reported that 2 ozark view self-starting, variable screws; size ø4.0x18 mm backed out 1-3 months post-operatively.Revision surgery has occurred.This report captures the first of the two screws.
Additional Manufacturer Narrative
B.5.: updated to reflect patient fusion.H.3: corrected to 'hospital retained device'.Functional inspection, dimensional inspection, and material analysis were unable to be performed as the device was not available for evaluation.However, a radiographic image provided and both screws were found to have been fractured at the caudal-most level of the construct.The construct was composed of a two (2) level plate and six (6) screws.A review of the device and complaint history records could not be performed as a valid lot code was not identified.It is not clear what caused the screws to fracture, although it is possible that factors such as pseudoarthrosis contributed to the issue.Although it was reported that fusion had been achieved, it is not clear if fusion was properly achieved since the construct was reported to have been broken two (2) months after surgery.Ultimately, no root cause for the failure could be determined based on the available information.H3 other text : hospital retained device.
Event or Problem Description
Physician reported that 2 ozark view self-starting, variable screws; size ø4.0x18 mm backed out 1-3 months post-operatively.The patient fused and revision surgery was performed.This report captures the first of the two screws.
Additional Manufacturer Narrative
Correction was made to b2 from 'blank' to 'required intervention to prevent permanent impairment/damage (devices).'.
Event or Problem Description
Physician reported that 2 ozark view self-starting, variable screws; size ø4.0x18 mm backed out 1-3 months post-operatively.The patient fused and revision surgery was performed.This report captures the first of the two screws.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE 4.0X18 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9759409
• Report Number: 3004774118-2020-00021
• Device Sequence Number: 2456875
• Product Code: KWQ
• UDI-Device Identifier: 10888857393400
• UDI-Public: 10888857393400
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/23/2020

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: 8801-04018DA
• Device Catalogue Number: 8801-04018DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 09/29/2020; 10/29/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/30/2020; 10/27/2020; 11/23/2020
• 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: Required Intervention