MAUDE Adverse Event Report: HDC S.R.L. SPIDERSCREW K1; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	SCL-1510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
When the doctor tried to screw a spider screw into the bone of a 15-year old male patient, the screw broke in half.It was reported that the doctor predrilled before trying to place the screw.The complaint form indicated that the patient was not harmed but merely inconvenienced, and the patient questionnaire sent in subsequently by the doctor also indicated there was no patient injury but a product/performance issue.The broken device was retrieved from the patient's mouth and the patient did not swallow any portion of the device.No hospital visit was required.The doctor mentioned on the patient questionnaire that if the device malfunction were to recur, it would not likely cause or contribute to a death or serious injury.Despite the fact that the doctor reported no patient injury, ot decided to report this because the doctor did prescribe ibuprofen, and a bone graft was placed after the broken screw was removed.A follow-up appointment was also required to check whether the bone graft was healed and a new spider screw could be inserted.

• Brand Name: SPIDERSCREW K1
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): HDC S.R.L.; via dei mestieri 5/7; thiene vicenza, it 36016, ; IT
• MDR Report Key: 15323032
• Report Number: 1056191-2022-00001
• Device Sequence Number: 17424421
• Product Code: DZE
• UDI-Device Identifier: 08057013140485
• UDI-Public: 08057013140485
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: SCL-1510
• Device Catalogue Number: SCL-1510
• Device Lot Number: C3069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2022
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2022
• 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: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male