MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW

Model Number 25-878-05-91

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problem Impaired Healing (2378)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Multiple mdr reports were filed for this patient.Mdr: 9610905-2022-00023.

Event Description

It was reported that screws became loose due to patient grinding their teeth.They were removed and replaced.

Manufacturer Narrative

An investigation was performed in the lab and there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.Review of the device history records was not possible due to no lot number being identified.The investigation results conclude that the root cause for this failure could not be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 14498335
• MDR Text Key: 292802622
• Report Number: 9610905-2022-00022
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888118047694
• UDI-Public: (01)00888118047694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971297
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-878-05-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 115 KG