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

Model Number	SCL-1510
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint received on 8/2/2023 and supporting documents (spider screw performance questionnaire and adverse event review employee / patient questionnaire) state that an 8mm spider screw was replaced after becoming mobile with the 10mm spider screw, which is the subject of this complaint.The head of the spider screw broke off at the last slight adjustment while it was being placed in the patient's mouth (on palatal between teeth # 3 & 4).It was reported that no drill was used to place the screw.The head of the screw was removed from the patient's mouth with no incident and no portion of the device was swallowed.Afterwards, the periodontal flap was opened to allow a grip on the broken screw, and the remainder of the screw was removed from the bone.The complaint form indicated that the 36-year-old patient was not injured during the device breakage.In addition, no doctor or hospital visit was required and no prescription medications were needed.The patient required a routine follow-up visit for surgical post op.The doctor's office indicated that if the device malfunction were to recur, it would likely cause or contribute to a death or serious injury because the patient could swallow or aspirate the broken-off piece.Due to the nature of this device malfunction and the potential of a serious injury, ortho technology decided to report this complaint to the fda.

• 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, 36016 ; IT 36016
• MDR Report Key: 17619473
• Report Number: 1056191-2023-00001
• Device Sequence Number: 20372091
• Product Code: DZE
• UDI-Device Identifier: 08057013140485
• UDI-Public: 08057013140485
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCL-1510
• Device Catalogue Number: SCL-1510
• Device Lot Number: C3239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/02/2023
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• 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: 36 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2023