Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB 2/DM; STIMULATOR, INVASIVE BONE GROWTH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EBI, LLC. SPF-XL IIB 2/DM; STIMULATOR, INVASIVE BONE GROWTH Back to Search Results
Model Number N/A
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet polaris translation screws.Therapy date: (b)(6) 2020.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3012447612-2020-00415, 3012447612-2020-00416, 3012447612-2020-00417, 3012447612-2020-00418, 3012447612-2020-00419, 3012447612-2020-00420, 3012447612-2020-00421, 3012447612-2020-00422, 3012447612-2020-00423, 3012447612-2020-00424, 3012447612-2020-00425.
 
Event Description
It was reported that there was an interaction between the spf xl iib 2/dm and the cobalt chrome of the polaris translation screws.As a result, multiple screws disassembled.A revision surgery was performed to remove the screws.It was reported that no further information is available.
 
Manufacturer Narrative
This follow up is being submitted to relay additional information.The device was not returned for evaluation as it is still implanted in the patient.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: b4: date of this report added.G1-g2: contact office updated.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: method code updated to 4114: device not returned.H6: method code updated to 3331: analysis of production records.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives/data.
 
Event Description
It was reported that there was an interaction between the spf xl iib 2/dm and the cobalt chrome of the polaris translation screws.As a result, multiple screws disassembled.A revision surgery was performed to remove the screws.It was reported that no further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPF-XL IIB 2/DM
Type of Device
STIMULATOR, INVASIVE BONE GROWTH
Manufacturer (Section D)
EBI, LLC.
399 jefferson road
parsippany NJ 07054
MDR Report Key10367782
MDR Text Key206970714
Report Number0002242816-2020-00083
Device Sequence Number1
Product Code LOE
UDI-Device Identifier00812301020089
UDI-Public00812301020089
Combination Product (y/n)N
PMA/PMN Number
P850035/S023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/30/2021
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number10-1335M
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received08/05/2020
Supplement Dates Manufacturer Received07/08/2020
Supplement Dates FDA Received01/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
-
-