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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM

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K2M, INC. MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 6201-35035
Device Problem Device Issue (2379)
Patient Problem No Information (3190)
Event Date 05/09/2016
Event Type  Malfunction  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. The product has not yet been returned to manufacturer for evaluation, and a thorough investigation could not be completed at this time. When more information becomes available manufacturer will file a follow-up report. Not received.

 
Event Description

It was reported to k2m, inc on (b)(6) 2016 that a uniplanar screw was unable to be fully locked intra-op and was replaced at that time.

 
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted. All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures. A review of the manufacturing and inspection records did not reveal any contributing information/trends. The damage to the lips of the outer collet of the returned screw is consistent with instrument misalignment. Once the lips are compromised, it becomes difficult to lock the screw. This likely happened to the screws that remain in the patient, although no definitive root cause can be determined.

 
Event Description

It was reported to k2m, inc on (b)(6) 2016 that a uniplanar screw was unable to be fully locked intra-op and was replaced at that time.

 
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Brand NameMESA SPINAL SYSTEM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
sandra gilbert
600 hope parkway se
leesburg, VA 20175
5719192000
MDR Report Key5697965
MDR Text Key46514200
Report Number3004774118-2016-00034
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number6201-35035
Device LOT NumberDWWU
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/12/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/27/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/03/2016 Patient Sequence Number: 1
Treatment
6201-05535 LOTS UNKNOWN
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