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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST® SPINAL SYSTEM; ORTHOSIS SPINAL FIXATION

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K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST® SPINAL SYSTEM; ORTHOSIS SPINAL FIXATION Back to Search Results
Catalog Number 2901-10001
Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(4) 2019 it was reported to k2m, inc.That a set screw backed-out, loosened or disengaged approximately 24 months post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00013).
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint the set screw exhibited signs of use, including abrasions along the superior face and threads.A radial wear pattern was present on the inferior surface of the implant, indicating that the rod may not have been fully reduced into the screw head during final tightening.Improper reduction may result in dynamic motion within the assembly, leading to failure post-operatively.
 
Event Description
On (b)(6) 2019 it was reported to k2m, that a set screw backed, loosened disengage approximately 24 month post-operatively.Patient was revised on (b)(6) 2019.(related to 3004774118-2019-00013).
 
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Brand Name
EVEREST® SPINAL SYSTEM
Type of Device
ORTHOSIS SPINAL FIXATION
Manufacturer (Section D)
K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
600 hope parkway se
leesburg VA 20175
MDR Report Key8381519
MDR Text Key137513301
Report Number3004774118-2019-00014
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/08/2019
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 Number2901-10001
Device Lot NumberFGGV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received03/01/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2911-06550 LOT FNYJ; 299-06550 LOT FNYJ; 299-06550, LOT FNYJ
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight73
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