Model Number 51-610-60-91 |
Device Problems
Use of Device Problem (1670); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00253.
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Event Description
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It was reported the distractor was turn the incorrect way causing pain and the pins to become loose.The pins were removed, and the distractor will be removed on an unknown date.
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Manufacturer Narrative
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An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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