MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GENDEX EXPERT DC; DENTAL EXTRA ORAL SOURCE X-RAY UNIT

Model Number EXPERT DC

Device Problems Crack (1135); Device Tipped Over (2589); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

The top mounting bolt became dislodged from the mounting surface due to improper installation.The stress of not having the top bolt securely fastened left the weight of the unit on the bottom bolt, causing the casting to crack and the unit to lean forward.The expert dc installation manual (032-0204-en) provides instructions for proper cabinet mount installations.No patients were involved and no injuries have been reported.This concludes our investigation.

Event Description

The customer reported that the x-ray unit's top bolt dislodged in the dental cabinet causing the unit to lean forward leading to the bottom of the casting becoming cracked.The unit remained in the cabinet.No patients were involved and no injuries have been reported.

• Brand Name: GENDEX EXPERT DC
• Type of Device: DENTAL EXTRA ORAL SOURCE X-RAY UNIT
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): GENDEX DENTAL SYSTEMS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 5192154
• MDR Text Key: 30422250
• Report Number: 2530069-2015-00006
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: EXPERT DC
• Device Catalogue Number: 1.006.2581
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1