MAUDE Adverse Event Report: K2M, INC. UNKNOWN ROD; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1101-04032F
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208); Injury (2348)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
A physician reported that a two screws, "fractured from the head," post-operatively.The patient has undergone revision surgery.This report will capture the first of two screws.
Event or Problem Description
A physician initially reported two post-operative screw fractures.However, subsequent investigation clarified that the event relevant to this patient was a rod fracture.It was reported that the rod fractured and protruded through the skin.The patient has undergone revision surgery.
Additional Manufacturer Narrative
The following fields have been updated following the receipt of clarifying information from the field: a1, b3, b5, b7, d1, d4, h6 health effect code, and h6 device code.
Event or Problem Description
A physician initially reported two post-operative screw fractures.However, subsequent investigation clarified that the event relevant to this patient was a rod fracture.It was reported that the rod fractured and protruded through the skin.The patient has undergone revision surgery.
Additional Manufacturer Narrative
The device was not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: UNKNOWN ROD
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10507926
• Report Number: 3004774118-2020-00204
• Device Sequence Number: 3546161
• Product Code: NKG
• UDI-Device Identifier: 10888857014374
• UDI-Public: 10888857014374
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 1101-04032F
• Device Catalogue Number: UNK_SPE
• Device Lot Number: PDH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 02/26/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 01/25/2021; 03/24/2021
• 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
• Patient Age: 4 YR
• Patient Weight: 14