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

Model Number	51-563-30-71
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the distractor was not advancing as expected.It was removed.
Additional Manufacturer Narrative
Lot numbers: 33484300; 33500960.
Additional 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 kls se.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause is organic matter present in the mechanism as no device issue was found.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: g1- updated company name address.

• Brand Name: DISTRACTION
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, de 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, deu FL 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 19447552
• Report Number: 9610905-2024-00030
• Device Sequence Number: 3213673
• Product Code: PBJ
• UDI-Device Identifier: 00888118114471
• UDI-Public: (01)00888118114471
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163315
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/09/2024

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: 51-563-30-71
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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 Sex: Unknown