MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 MULTI PURPOSE SKULL CLAMP

Model Number 3020-50

Device Problem Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Manufacturer Narrative

No investigation possible.Product not received for evaluation.

Event Description

During cranial operation in a child in one of (b)(6) hospital in (b)(6), the surgeon was using the multipurpose with pediatric pins.They claimed that the sys.Pins caused fraction in the patient head.The issued raised internal the hospital and situation is not good.

• Brand Name: DORO® QR3 MULTI PURPOSE SKULL CLAMP
• Type of Device: DORO® QR3 MULTI PURPOSE SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• MDR Report Key: 6803047
• MDR Text Key: 82978200
• Report Number: 3003923584-2017-00033
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2017

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: No Information
• Device Model Number: 3020-50
• Device Catalogue Number: 3020-50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention