Model Number 1555-35-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Date 11/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Medical records were received on (b)(6) 2021.Doi: unknown, dor: unknown, unknown affected side.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since 01-jan-2015.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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