MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG DISTRACTION, INTERNAL; DISTRACTOR

Model Number	51-565-09-09
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Received (b)(4) stating that at completion of distraction, the care provider noticed that the distractor arm was slightly bent.The device was in place, not broken and maintaining palatal width following distraction.Device distracted as planned.At this time no additional surgeries planned other than the removal of the device.Patient is doing well and not having any issues distracting.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.Process evaluation was also performed based off the lot number provided.The complaint percentage falls within the design risk limits adhered to at klm.The review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.Due to no device being returned the root cause for the failure cannot 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: DISTRACTION, INTERNAL
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6291338
• Report Number: 9610905-2017-00002
• Device Sequence Number: 1502710
• Product Code: MQN
• UDI-Device Identifier: 00888118099631
• UDI-Public: (01)00888118099631
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 51-565-09-09
• Device Lot Number: 32041143
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2016
• Supplement Date Received by Manufacturer: 01/03/2016
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: Other
• Patient Age: 24 YR