MAUDE Adverse Event Report: K2M, INC. ES2 HEX STRAIGHT ROD 5.5 X 65MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482807065
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an es2 hex straight rod fractured post-operatively.During intra-operative rod adjustment, the surgeon had difficulty attaching and detaching the rod inserter.After much trail and error the inserter was able to forcibly be removed.Intra-operative imaging was performed and found no device issue.However, post-operative imaging revealed the right rod hex (cranial side) was broken.There were no adverse consequences to the patient.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential root causes include: user error (unstable construct); incorrect or small-sized screws implanted; poor bone quality of patient; patient experiences a fall or trauma post-surgery; high activity level of patient post-surgery.Device remains implanted in patient.
Event or Problem Description
It was reported that an es2 hex straight rod fractured post-operatively.During intra-operative rod adjustment, the surgeon had difficulty attaching and detaching the rod inserter.After much trail and error the inserter was able to forcibly be removed.Intra-operative imaging was performed and found no device issue.However, post-operative imaging revealed the right rod hex (cranial side) was broken.There were no adverse consequences to the patient.Revision surgery has not been scheduled.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 65MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10838653
• Report Number: 0009617544-2020-00195
• Device Sequence Number: 17076809
• Product Code: NKB
• UDI-Device Identifier: 07613327001501
• UDI-Public: 07613327001501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 482807065
• Device Catalogue Number: 482807065
• Device Lot Number: 24F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR