MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION ANCHOR BOLT - LSB STYLE

Catalog Number	UNKNOWN
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the event description, (b)(6) from (b)(6) contacted ad-tech by email on (b)(6) 2017 regarding anchor bolts that broke.Two fractured anchor bolts were partially retrieved on an explant.This was a patient with non-convulsive seizures, and no overt trauma in the emu or theatre.One bolt was subsequently retrieved at craniotomy, another, in an uninvolved region, remains in situ.The products were not sent back to ad-tech for evaluation.Instead, a picture was sent showing the broken bolts.Based on the picture, the alleged deficiency in the complaint was confirmed.The investigation in still on-going.
Event or Problem Description
On (b)(6) 2017 a customer contacted ad-tech via email regarding anchor bolts that broke.It was stated that two fractured anchor bolts were partially retrieved on an explant.This was a patient with non-convulsive seizures, and no overt trauma in the emu or theatre.The customer also stated that one bolt was subsequently retrieved at craniotomy.Another one, in an uninvolved region, remained in situ.There is no known impact to the patient.Additional information has been requested.

• Brand Name: ANCHOR BOLT - LSB STYLE
• Common Device Name: ANCHOR BOLT - LSB STYLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORPORATION; 1901 william street; racine WI 53404
• MDR Report Key: 7022990
• Report Number: 2183456-2017-00010
• Device Sequence Number: 15220638
• Product Code: GCZ
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other