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

Model Number	8801-14018DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
It was reported that during a scheduled revision surgery for patient non union, an ozark fixed screw at c5 was discovered to have fractured post-operatively.The screw was removed and discarded.
Event or Problem Description
It was reported that during a scheduled revision surgery for patient non union, an ozark fixed screw at c5 was discovered to have fractured post-operatively.The screw was removed and discarded.
Additional Manufacturer Narrative
Visual inspection: the issue was confirmed through inspection of the associated imaging in a meeting with the surgeon.The construct spanned from c3-c5, and it was composed of a two (2) level plate, six (6) screws, and interbodies.One screw at the caudal-most level of the construct fractured at c5.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The screw fracture was observed during the scheduled revision surgery.It is likely that screw fractured due to delayed healing.According to the ozark surgical technique, if healing is delayed or does not occur, the implant could break, bend, or loosen.The cause of the reported event will be classified as 'patient factors issue'.

• Brand Name: FIXED SCREW, SELF-STARTING; 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: 11362743
• Report Number: 3004774118-2021-00057
• Device Sequence Number: 3335004
• Product Code: KWQ
• UDI-Device Identifier: 10888857392380
• UDI-Public: 10888857392380
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 8801-14018DA
• Device Catalogue Number: 8801-14018DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 115