MAUDE Adverse Event Report: K2M, INC. MESAMINI 90 SCREW; SIZE 4.0X32 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1101-04032F
Medical Device Problem Codes	Material Separation (1562); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
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 second of two screws.
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 second of two screws.
Additional Manufacturer Narrative
Corrected data: b.2.Has been populated to reflect "required intervention.".
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per mesa surgical technique: potential adverse events: 1.Adequately instruct the patient.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.2.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.3.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.4.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.Exact cause cannot be confirmed.Potential causes include user error during initial surgery, patient performs high activity level or patient experiences fall/ trauma.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.H3 other text : status and location 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 second of two screws.
Additional Manufacturer Narrative
Additional information indicates there is not a second device associated with this patient.The event is captured in mfr 3004774118-2020-00204.
Event or Problem Description
A physician initially reported that a two screws, "fractured from the head," post-operatively.This report had capture the second of two screws.Additional information was received which indicated the event relating to this patient involved only one device (captured in mfr 3004774118-2020-00204).

• Brand Name: MESAMINI 90 SCREW; SIZE 4.0X32 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10507944
• Report Number: 3004774118-2020-00203
• Device Sequence Number: 3546162
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/25/2021

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: 1101-04032F
• Device Lot Number: AVNL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 11/30/2020; 01/08/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/10/2020; 12/17/2020; 01/25/2021
• 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