MAUDE Adverse Event Report: KLS MARTIN SE & CO. KG DISTRACTION; DISTRACTOR

Model Number	51-424-25-71
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an additional surgery was done to flush out a blockage that prevented the device from turning as expected.Multiple mdr reports were filed for this patient.Mdr 9610905-2021-00121.
Additional Manufacturer Narrative
Possible lots: 33263729, 33281135.
Additional Manufacturer Narrative
An investigation was successfully completed.The results of the investigation have identified no manufacturing issues, no design issues and/or corrective actions necessary at this time.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Corrections d3 - company name change only g1 - company establishment and contact information updated only - typo g1 - contact office - manufacturing site name/address typo.

• Brand Name: DISTRACTION
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, FL 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 12964304
• Report Number: 9610905-2021-00105
• Device Sequence Number: 5424678
• Product Code: MQN
• UDI-Device Identifier: 00888118104861
• UDI-Public: (01)00888118104861
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161470
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 51-424-25-71
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 DA
• Patient Sex: Female