MAUDE Adverse Event Report: K2M. INC PYRENEES® CERVICAL PLATE; ANTERIOR CERVICAL PLATE

Catalog Number 208-42F36

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On 09.13.2018 it was reported to k2m, inc.That a plate backed out, loosened, disengaged approximately 4-6 month post-operatively.Patient was revised on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Inspection of the returned plate revealed minimal deformation in the proximal and distal retaining holes.The manufacturing and inspection records were reviewed and no relevant discrepancies were found.

Event Description

On (b)(6) 2018 it was reported to k2m, inc that a plate backed out, loosened, disengaged approximately 4-6 months post-operately.Patient was revised on (b)(6) 2018.( related to 3004774118-2018-00161).

• Brand Name: PYRENEES® CERVICAL PLATE
• Type of Device: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 7991251
• MDR Text Key: 124564178
• Report Number: 3004774118-2018-00162
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K063544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 208-42F36
• Device Lot Number: FNFV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 09/13/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 201-14016D LOT GFTK; 201-14016D LOT FNFV; 201-14016D LOT GDBP; 201-14016D LOT UNKNOWN; 201-14016D LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR