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: ZIMMER DENTAL RETAINING SQUARE RATCHET
  • 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
 

ZIMMER DENTAL RETAINING SQUARE RATCHET Back to Search Results
Catalog Number RSR
Device Problem Fracture (1260)
Patient Problems Edema (1820); Inflammation (1932)
Event Date 07/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the ratchet wrench fractured during manual insertion of implant.Implant could not be fully placed and was removed.Doctor sutured the site without placing any implant.It will be a wait of three months before rescheduling the patient for a new implant placement.
 
Event Description
It was reported that the ratchet wrench fractured during manual insertion of implant.Implant could not be fully placed and was removed.Doctor sutured the site without placing any implant.It will be a wait of three months before rescheduling the patient for a new implant placement.The ratchet fractured at head level and started rotating without giving the torque.
 
Manufacturer Narrative
The following sections have been updated: date of this report.Description of event.Date received by manufacturer.
 
Event Description
No further information available.
 
Manufacturer Narrative
After additional information, it was determined that this event no longer meets the criteria of a reportable event, that this event no longer met the requirements for reporting.As a result, the prior submissions for mfr- 0002023141-2018-00789 submitted on august 10, 2010 and mfr- 0002023141-2018-00789 submitted on oct 23, 2018 , are no longer considered a reportable event by the manufacturer and no further reports will be submitted for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RETAINING SQUARE RATCHET
Type of Device
RATCHET
Manufacturer (Section D)
ZIMMER DENTAL
6221 el camino real
carlsbad CA 92009
MDR Report Key7860963
MDR Text Key119709680
Report Number0002023141-2018-00789
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRSR
Device Lot Number63337508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN DENTAL IMPLANT; UNKNOWN DENTAL IMPLANT
Patient Outcome(s) Required Intervention;
Patient Age38 YR
Patient Weight65
-
-