MAUDE Adverse Event Report: SYNTHES GMBH CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5; BONE PLATE

Catalog Number 400.835

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in belgium as follows: it was reported that on (b)(6) 2023, five (5) screws could not be properly fixed during the placement, and the screw heads broke off.The screws were placed but with missing screw heads.These screws were still implanted and 2 additional screws were placed for proper fixation.This report involves one (1) ti low profile neuro screw self-drilling 5mm.This is report 4 of 5 for (b)(4).

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.H3 other text : device not returned.

• Brand Name: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17586760
• MDR Text Key: 321741667
• Report Number: 8030965-2023-10531
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5.; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5.; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5.; CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5.
• Patient Age: 62 YR
• Patient Sex: Female