• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED ORTHO SOLUTIONS DRILL BITS AO QC DRILL BIT 2.5/110/85 (GOLD)

  • 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
 

ORTHO SOLUTIONS UK LIMITED ORTHO SOLUTIONS DRILL BITS AO QC DRILL BIT 2.5/110/85 (GOLD) Back to Search Results
Model Number OS200125
Device Problem Fracture
Event Date 12/12/2019
Event Type  Malfunction  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHO SOLUTIONS DRILL BITS
Type of DeviceAO QC DRILL BIT 2.5/110/85 (GOLD)
Manufacturer (Section D)
ORTHO SOLUTIONS UK LIMITED
west station business park
spital road
maldon, essex, CM9 6 FF
UK  CM9 6FF
Manufacturer (Section G)
ORTHO SOLUTIONS UK LIMITED
west station business park
spital road
maldon, essex, CM9 6 FF
UK  CM9 6FF
Manufacturer Contact
samuel chong
unit 5, west station business
spital road
maldon, essex  CM9 6-FF
  CM9 6FF
MDR Report Key9602143
Report Number3008951116-2020-00002
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOS200125
Device Catalogue NumberOS200125
Device LOT Number1A1347
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2019
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: 01/17/2020 Patient Sequence Number: 1
-
-